regulation

One of my scientific heroes is Bernard Katz. The closing words of his inaugural lecture, as professor of biophysics at UCL, hang on the wall of my office as a salutory reminder to refrain from talking about ‘how the brain works’. After speaking about his discoveries about synaptic transmission, he ended thus.

"My time is up and very glad I am, because I have been leading myself right up to a domain on which I should not dare to trespass, not even in an Inaugural Lecture. This domain contains the awkward problems of mind and matter about which so much has been talked and so little can be said, and having told you of my pedestrian disposition, I hope you will give me leave to stop at this point and not to hazard any further guesses."

"Almost every single nutrient imaginable has peer reviewed publications associating it with almost any outcome."

and the subtitle

“Definitive solutions won’t come from another million observational papers or small randomized trials“.

Being a bit obsessive about causality, this paper is music to my ears. The problem of causality was understood perfectly by Samuel Johnson, in 1756, and he was a lexicographer, not a scientist. Yet it’s widely ignored by epidemiologists.

The problem of causality is often mentioned in the introduction to papers that describe survey data, yet by the end of the paper, it’s usually forgotten, and public health advice is issued.

Ioannidis’ editorial vindicates my own views, as an amateur epidemiologist, on the results of the endless surveys of diet and health.

Diet and health. What can you believe: or does bacon kill you (2009) in which I look at the World Cancer Research Fund’s evidence for causality (next to none in my opinion). Through this I got to know Gary Taubes, whose explanation of causality in the New York Times is the best popular account I’ve ever seen.

There is nothing new about the problem. It’s been written about many times. Young & Karr (Significance, 8, 116 – 120, 2011: get pdf) said "Any claim coming from an observational study is most likely to be wrong". Out of 52 claims made in 12 observational studies, not a single one was confirmed when tested by randomised controlled trials.

Another article cited by Ioannidis, "Myths, Presumptions, and Facts about Obesity" (Casazza et al , NEJM, 2013), debunks many myths, but the list of conflicts of interests declared by the authors is truly horrendous (and at least one of their conclusions has been challenged, albeit by people with funding from Kellogg’s). The frequent conflicts of interest in nutrition research make a bad situation even worse.

The quotation in bold type continues thus.

"On 25 October 2013, PubMed listed 291 papers with the keywords “coffee OR caffeine” and 741 with “soy,” many of which referred to associations. In this literature of epidemic proportions, how many results are correct? Many findings are entirely implausible. Relative risks that suggest we can halve the burden of cancer with just a couple of servings a day of a single nutrient still circulate widely in peer reviewed journals.

However, on the basis of dozens of randomized trials, single nutrients are unlikely to have relative risks less than 0.90 for major clinical outcomes when extreme tertiles of population intake are compared—most are greater than 0.95. For overall mortality, relative risks are typically greater than 0.995, if not entirely null. The respective absolute risk differences would be trivial. Observational studies and even randomized trials of single nutrients seem hopeless, with rare exceptions. Even minimal confounding or other biases create noise that exceeds any genuine effect. Big datasets just confer spurious precision status to noise."

And, later,

"According to the latest burden of disease study, 26% of deaths and 14% of disability adjusted life years in the United States are attributed to dietary risk factors, even without counting the impact of obesity. No other risk factor comes anywhere close to diet in these calculations (not even tobacco and physical inactivity). I suspect this is yet another implausible result. It builds on risk estimates from the same data of largely implausible nutritional studies discussed above. Moreover, socioeconomic factors are not considered at all, although they may be at the root of health problems. Poor diet may partly be a correlate or one of several paths through which social factors operate on health."

Another field that is notorious for producing false positives, wirh false attribution of causality, is the detection of biomarkers. A critical discussion can be found in the paper by Broadhurst & Kell (2006), "False discoveries in metabolomics and related experiments".

"Since the early days of transcriptome analysis (Golub et al., 1999), many workers have looked to detect different gene expression in cancerous versus normal tissues. Partly because of the expense of transcriptomics (and the inherent noise in such data (Schena, 2000; Tu et al., 2002; Cui and Churchill, 2003; Liang and Kelemen, 2006)), the numbers of samples and their replicates is often small while the number of candidate genes is typically in the thousands. Given the above, there is clearly a great danger that most of these will not in practice withstand scrutiny on deeper analysis (despite the ease with which one can create beautiful heat maps and any number of ‘just-so’ stories to explain the biological relevance of anything that is found in preliminary studies!). This turns out to be the case, and we review a recent analysis (Ein-Dor et al., 2006) of a variety of such studies."

The fields of metabolomics, proteomics and transcriptomics are plagued by statistical problems (as well as being saddled with ghastly pretentious names).

What’s to be done?

[Page39] “But why should nonscientists care one iota about something as esoteric as causal inference? I believe that the answer to this question is because the making of causal inferences is part of our job description as Homo Sapiens.”

The problem, of course, is that humans are very good at attributing causality when it does not exist. That has led to confusion between correlation and cause on an industrial scale, not least in attempts to work out the effects of diet on health.

More than in any other field it is hard to do the RCTs that could, in principle, sort out the problem. It’s hard to allocate people at random to different diets, and even harder to make people stick to those diets for the many years that are needed.

We can probably say by now that no individual food carries a large risk, or affords very much protection. The fact that we are looking for quite small effects means that even when RCTs are possible huge samples will be needed to get clear answers. Most RCTs are too short, and too small (under-powered) and that leads to overestimation of the size of effects.

"Supplements" of one sort and another are ubiquitous in sports. Nobody knows whether they work, and the margin between winning and losing is so tiny that it’s very doubtful whether we ever will know. We can expect irresponsible claims to continue unabated.

The best thing that can be done in the short term is to stop doing large observational studies altogether. It’s now clear that inferences made from them are likely to be wrong. And, sad to say, we need to view with great skepticism anything that is funded by the food industry. And make a start on large RCTs whenever that is possible. Perhaps the hardest goal of all is to end the "publish or perish" culture which does so much to prevent the sort of long term experiments which would give the information we want.

Ioannidis’ article ends with the statement

"I am co-investigator in a randomized trial of a low carbohydrate versus low fat diet that is funded by the US National Institutes of Health and the non-profit Nutrition Science Initiative."

It seems he is putting his money where his mouth is.

Until we have the results, we shall continue to be bombarded with conflicting claims made by people who are doing their best with flawed methods, as well as by those trying to sell fad diets. Don’t believe them. The famous "5-a-day" advice that we are constantly bombarded with does no harm, but it has no sound basis.

As far as I can guess, the only sound advice about healthy eating for most people is

don’t eat too much

don’t eat all the same thing

You can’t make much money out of that advice.

No doubt that is why you don’t hear it very often.

Follow-up

Two relevant papers that show the unreliability of observational studies,

"Nearly 80,000 observational studies were published in the decade 1990–2000 (Naik 2012). In the following decade, the number of studies grew to more than 260,000". Madigan et al. (2014)

On 20 March 2014, I gave a talk on this topic at the Cambridge Science Festival (more here). After the event my host, Yvonne Noblis, sent me some (doubtless cherry-picked) feedback she’d had about the talk.

Ofquack was created at the instigation of HRH the Prince of Wales, at public expense, as a means of protecting the delusional beliefs of quacks from criticism. I worked for them for a while, and know from the inside that their regulation is a bad joke.

When complaints were made about untrue claims made by ‘reflexologists’, the complaints were upheld but they didn’t even reach the Conduct and Competence committee, on the grounds that the reflexologists really believed the falsehoods that they’d been taught. Therefore, by the Humpty Dumpty logic of the CNHC, their fitness to practise was not affected by their untrue claims. You can read the account of this bizarre incident by the person who submitted the complaints, Simon Perry.

In fact in the whole history of the CNHC, it has received a large number of complaints, but only one has ever been considered by their Conduct and Competence Committee. The rest have been dismissed before they were considered properly. That alone makes their claim to be a regulator seem ridiculous.

The CNHC did tell its registrants to stop making unjustified claims, but it has been utterly ineffective in enforcing that ruling. In May 2013, another 100 complaints were submitted and no doubt they will be brushed aside too: see Endemic problems with CNHC registrants..

It will be fascinating to see how the CNHC tries to escape from the grave that it has dug for itself.

If the CNHC implements properly its own code of conduct, few people will sign up and the CNHC will die. If it fails to implement its own code of conduct it would be shown to be a dishonest sham.

In February of this year (2013), I visited the PSA with colleagues from the Nightingale Collaboration. We were received cordially enough, but they seemed to be bureaucrats with no real understanding of science. We tried to explain to them the fundamental dilemma of the regulation of quacks, namely that no amount of training will help when the training teaches things that aren’t true. They were made aware of all of the problems described above. But despite that, they ended up endorsing the CNHC.

How on earth did the PSA manage to approve an obviously ineffective ‘regulator’?

Standard 6: the organisation demonstrates that there is a defined knowledge base underpinning the health and social care occupations covered by its register or, alternatively, how it is actively developing one. The organisation makes the defined knowledge base or its development explicit to the public.

The Professional Standards Authority recognises that not all disciplines are underpinned by evidence of proven therapeutic value. Some disciplines are subject to controlled randomized trials, others are based on qualitative evidence. Some rely on anecdotes. Nevertheless, these disciplines are legal and the public choose to use them. The Authority requires organisations to make the knowledge base/its development clear to the public so that they may make informed decisions.

Since all 15 occupations that are “regulated” by the CNHC fall into the last category. they “rely on anecdotes”, you would imagine the fact that “The Authority requires organisations to make the knowledge base/its development clear to the public” would mean that the CNHC was required to make a clear statement that reiki, reflexology etc are based solely on anecdote. Of course the CNHC does no such thing. For example, the CNHC’s official definition of reflexology says

Reflexology is a complementary therapy based on the belief that there are reflex areas in the feet and hands which are believed to correspond to all organs and parts of the body

There is, of course, not the slightest reason to think such connections exist, but the CNHC gives no hint whatsoever of that inconvenient fact. The word “anecdote” is used by the PSA but occurs nowhere on the CNHC’s web site.

It is very clear that the CNHC fails standard 6.

But the PSA managed to summon up the following weasel words to get around this glaring failure:

“The professional associations (that verify eligibility for CNHC registration) were actively involved in defining the knowledge base for each of the 15 professions. The Panel further noted that Skills for Health has lead responsibility for writing and reviewing the National Occupational Standards (NOS) for the occupations CNHC registers and that all NOS have to meet the quality criteria set by the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors. The Panel considered evidence provided and noted that the applicant demonstrated that there is a defined knowledge base underpinning the occupations covered by its registers. The knowledge base was explicit to the public”.

The PSA, rather than engaging their own brains, simply defer to two other joke organisations, Skills for Health and National Occupational Standards. But it is quite obvious that for things like reiki, reflexology and craniosacral therapy, the “knowledge base” consists entirely of made-up nonsense. Any fool can see that (but not, it seems, the PSA).

Skills for Health lists made-up, HR style, “competencies” for everything under the sun. When I got them to admit that their efforts on distance-healing etc had been drafted by the Prince of Wales’ Foundation, the conversation with Skills for Health became surreal (recorded in January 2008)

DC. Well yes the Prince of Wales would like that. His views on medicine are well known, and they are nothing if not bizarre. Haha are you going to have competencies in talking to trees perhaps?

“You’d have to talk to LANTRA, the land-based organisation for that.”

DC. I’m sorry, I have to talk to whom?

“LANTRA which is the sector council for the land-based industries uh, sector, not with us sorry . . . areas such as horticulture etc.”

DC. We are talking about medicine aren’t we? Not horticulture.

“You just gave me an example of talking to trees, that’s outside our remit ”

You couldn’t make it up, but it’s true. And the Professional Standards Authority rely on what these jokers say.

“Reflexology is the study and practice of treating reflex points and areas in the feet and hands that relate to corresponding parts of the body. Using precise hand and finger techniques a reflexologist can improve circulation, induce relaxation and enable homeostasis. These three outcomes can activate the body’s own healing systems to heal and prevent ill health.”

This is crass, made-up nonsense. Of course there are no connections between “areas in the feet and hands that relate to corresponding parts of the body” and no reason to think that reflexology is anything more than foot massage. That a very expensive body, paid for by you and me, can propagate such preposterous nonsense is worrying. That the PSA should rely on them is even more worrying.

National Occupational Standards is yet another organisation that is utterly dimwitted about medical matters, but if you look up reflexology you are simply referred to Skills for Health, as above.

UK Commission for Employment and Skills
(UKCES) is a new one on me. The PSA says that “the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors” It is only too obvious that the UKCES leadership team have failed utterly to do their job when it comes to made-up medicine. None of them know much about medicine. It’s true that their chairman did once work for SmithKline Beecham, but as a marketer of Lucozade, a job which anyone with much knowledge of science would not find comfortable..

You don’t need to know much medicine to spot junk. I see no excuse for their failure.

9a) Sets appropriate educational standards that enable its registrants to practise competently the occupation(s) covered by its register. In setting its standards the organisation takes account of the following factors:

The nature and extent of risk to service users and the public

The nature and extent of knowledge, skill and experience required to provide
service users and the public with good quality care

and later

9b) Ensures that registrants who assess the health needs of service users and provide any form of care and treatment are equipped to:

Recognise and interpret clinical signs of impairment

Recognise where a presenting problem may mask underlying pathologies

Have sufficient knowledge of human disease and social determinants of health to identify where service users may require referral to another health or social care professional.

Anyone who imagines for a moment that a reflexologist or a craniosacral therapist is competent to diagnose a subarachnoid haemorrhage or malaria must need their head examining. In any case, the CNHC has already admitted that their registrants are taught things that aren’t true, so more training presumably means more inculcation of myths.

“The Panel noted that practitioners must meet, as a minimum, the National Occupational Standards for safe and competent practice. This is verified by the professional associations, who have in turn provided written undertakings to CNHC affirming that there are processes in place to verify the training and skills outcomes of their members to the NOS”

Just two problems there. The NOS standards themselves are utterly delusional. And checking them is left to the quacks themselves. To be fair, the PSA weren’t quite happy with this, but after an exchange of letters, minor changes enabled the boxes to be ticked and the PSA said “The Panel was now satisfied from the evidence provided, that this Standard had been
met”.

What’s wrong with regulators?

This saga is typical of many other cases of regulators doing more harm than good. Regulators are sometimes quacks themselves, in which case one isn’t surprised at their failure to regulate.

But organisations like the Professional Standards Authority and Skills for Health are not (mostly) quacks themselves. So how do they end up giving credence to nonsense? I find that very hard to comprehend, but here are a few ideas.

(1) They have little scientific education and are not really capable of critical thought

(2) Perhaps even more important, they lack all curiosity. It isn’t very hard to dig under the carapace of quack organisations, but rather than finding out for themselves, the bureaucrats of the PSA are satisfied by reassuring letters that allow them to tick their boxes and get home.

(3) A third intriguing possibility is that people like the PSA yield to political pressure. The Department of Health is deeply unscientific and clearly has no idea what to do about alternative medicine. They have still done nothing at all about herbal medicine, traditional Chinese medicine or homeopathy, after many years of wavering. My guess is that they see the CNHC as an organisation that gives the appearance that they’ve done something about reiki etc. I wonder whether they applied pressure to the PSA to accredit CNHC, despite it clearly breaking their own rules. I have sent a request under the Freedom of Information Act in an attempt to discover if the Department of Health has misbehaved in the way it did when it attempted to override NHS Choices.

What can be done?

This is just the latest of many examples of regulators who not only fail to help but actually do harm by giving their stamp of approval to mickey mouse organisations like the CNHC. Most of the worst quangos survived the “bonfire of the quangos”.. The bonfire should have started with the PSA, CNHC and Skills for Health. They cost a lot and do harm.

There is a much simpler answer. There is a good legal case that much of alternative medicine is illegal. All one has to do is to enforce the existing law. Nobody would object to quacks if they stopped making false claims (though whether they could stay in business if they stopped exaggerating is debatable). There is only one organisation that has done a good job when it comes to truthfulness. That is the Advertising Standards Authority. But the ASA can do nothing apart from telling people to change the wording of their advertisements, and even that is often ignored.

The responsibility for enforcing the Consumer Protection Law is Trading Standards. They have consistently failed to do their job (see Medico-Legal Journal, Rose et al., 2012. “Spurious Claims for Health-care Products“.

If they did their job of prosecuting people who defraud the public with false claims, the problem would be solved.

I was asked by Nature Medicine (which is published in the USA) to write a review of Paul Offit’s new book. He’s something of a hero, so of course I agreed. The editor asked me to make some changes to the first draft, which I did. Then the editor concerned sent me this letter.

Thank you for the revised version of the book review.

The chief editor of the journal took a look at your piece, and he thought that it would be a good idea to run it past our legal counsel owing to the strong opinions expressed in the piece in relation to specific individuals. I regret to say that the lawyers have advised us against publishing the review.

After that I tried the UK Conversation. They had done a pretty good job with my post on the baleful influence of royals on medicine. They were more helpful then Nature Medicine, but for some reason that I can’t begin to understand, they insisted that I should not name Nature Medicine, but to refer only to "a leading journal". And they wanted me not to name Harvard in the last paragraph. I’m still baffled about why. But it seemed to me that editorial interference had gone too far, so rather than have an editor re-write my review, I withdrew it.

It is precisely this sort of timidity that allows purveyors of quackery such success with their bait and switch tactics. The fact that people seem so terrified to be frank must be part of the reason why Harvard, Yale and the rest have shrugged their shoulders and allowed nonsense medicine to penetrate so deeply into their medical schools. It’s also why blogs now are often better sources of information than established journals.

Here is the review. I see nothing defamatory in it.

Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine

Paul A. Offit
Harper, 2013
336 pp., hardcover $26.99
ISBN: 0062222961

Reviewed by David Colquhoun Research Professor of Pharmacology, UCL.

Here’s an odd thing. There is a group of people who advocate the silly idea that you can cure all ills by stuffing yourself with expensive pills, made by large and unscrupulous Pharma companies. No, I’m not talking about pharmacologists or doctors or dietitians. They mostly say that stuffing yourself with pills is often useless and sometimes harmful, because that’s what the evidence says .

Rather, the pill pushers are the true believers in the alternative realities of the “supplement” industry. They seem blithely unaware that the manufacturers are mostly the same big pharma companies that they blame for trying to suppress “natural remedies”. Far from trying to suppress them, pharma companies love the supplement industry because little research is needed and there are few restrictions on the claims that can be made.

Paul Offit’s excellent book concentrates on alternative medicine in the USA, with little mention of the rest of the world. He describes how American pork barrel politics have given supplement hucksters an almost unrestricted right to make stuff up.

Following the thalidomide tragedy, which led to birth defects in babies in the 1950s and 60s, many countries passed laws that required evidence that a drug was both effective and safe before it could be sold. This was mandate by the Kefauver-Harris amendment (1961) in the USA and the Medicines Act (1968) in the UK. Laws like that upset the quacks, and in the UK the quacks got a free pass, a ‘licence of right‘, largely still in existence.

In order to sell a herbal concoction in the UK you need to present no evidence at all that it works, just evidence of safety, in return for which you get a reassuring certification mark and freedom to use misleading brand names and labels.

Tradional herbal mark

In the USA the restrictions didn’t last long. Offit describes how a lobby group for vitamin sellers, the National Health Federation, had a board made up of quacks, some of whom, according to Offit (page 73) had convictions. They found an ally in Senator William Proxmire who introduced in 1975 an amendment that banned the Food and Drugs Administration (FDA) from regulating the safety of megavitamins. Tragically, this bill was even supported by the previously-respected scientist Linus Pauling. Offit tells us that “to Proxmire” became a verb meaning to obstruct science for political gain.

This act iniquitously defined a “supplement” as “a product intended to supplement the diet that bears or contains one or more of the following ingredients: a vitamin, a mineral, an herb or other botanical, or an amino acid”. At a stroke, herbs were redefined as foods. There was no need to submit any evidence of either efficacy or even of safety, before marketing anything. All a manufacturer had to do to sell almost any herbal drug or megadose vitamin was to describe it as a “dietary supplement”. The lobbying to get this law through was based on appealing to the Tea Party tendency –get the government’s hands off our vitamins. And it was helped by ‘celebrities’ such as Sissy Spacek and Mel Gibson (it’s impossible to tell whether they really believed in the magic of vitamins, or whether they were paid, or had Tea Party sympathies).

Offit’s discussion of vaccination is a heartbreaking story of venom and misinformation. As co-inventor of the first rotavirus vaccine he’s responsible for saving many lives around the world. But he, perhaps more than anyone, suffered from the autism myth started by the falsified work of Andrew Wakefield.

The scientific community took the question seriously and soon many studies showed absolutely no link between vaccination and autism. But evidence did not seem to interest the alternative world. Rather than Offit being lauded as a saver of children’s lives, he describes how he was subjected to death threats and resorted to having armed guards at meetings.

Again, Offit tells us how celebrities were able to sway public opinion For example (chapter 6), the actress Jenny McCarthy and talk-show hostess Oprah Winfrey promoted, only too successfully, the vaccine-autism link despite abundant evidence that it didn’t exist, and promoted a number of theories that were not supported by any evidence, such as the idea that autism can be “cured” by mega-doses of vitamins and supplements.

Of course vaccines like the one for rotavirus can’t be developed without pharmaceutical companies because, as Offit says, only they "have the resources and expertise to make a vaccine. We can’t make it in our garage". When the Children’s Hospital of Philadelphia sold its royalty stake in the rotavirus vaccine for $182 million, Offit received an undisclosed share of the intellectual property, “in the millions ”.

That’s exactly what universities love. We are encouraged constantly to collaborate with industry, and, in the process, make money for the university. It’s also what Wakefield, and the Royal Free Hospital where he worked, hoped to do. But sadly, these events led to Offit being called names such as “Dr Proffit” and “Biostitute” (to rhyme with “prostitute”) by people like Jenny McCarthy and Robert F. Kennedy Jr. The conspiritorialist public lapped up this abuse, but appeared not to notice that many quacks have become far richer by peddling cures that do not work.

One lesson from this sad story is that we need to think more about the potential for money to lead to good science being disbelieved, and sometimes to corrupt science.

Everyone should buy this book, and weep for the gullibility and corruption that it describes.

Abraham Flexner, whose 1910 report first put US medicine on a sound scientific footing, must be turning in his grave.

Follow-up

30 August 2013

Quack lobby groups got a clause inserted into Obamacare that will make any attempt to evaluate whether a treatment actually works will leave insurance companies open to legal action for "discrimination".

"Discrimination? Yes! We must not allow the government to exclude health care providers just because those providers don’t cure anything."

The latest piece of well-organised corporate corruption by well-funded lobbyists is revealed by Steven Salzberg, in Forbes Magazine. The chaos in the US health system makes one even more grateful for the NHS and for the evaluation of effectiveness of treatments by NICE.

The harm done by the government’s endorsement of herbal products could be ameliorated if they were labelled honestly. The labelling is a matter for the Medicines and Healthcare products Regulatory Authority (MHRA), and for a while I have been writing to the head of the MRH, Kent Woods, and to Richard Woodfield (head of MHRA herbal medicine policy), in an attempt to work out their reasons for not telling the consumer the simple truth.

The Traditional Herbal Registration (THR) scheme allows herbal medicines that are registered on this scheme to be sold if they are safe, and have been in use for 30 years. There is need to supply any information whatsoever about whether they work or not. That itself is very odd, given that the MHRA’s strap line says

"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe."

In the case of herbals, the bit about ensuring that medicines work has been brushed under the carpet.

A typical dishonest label

Note, first of all, the therapeutic claim in the brand name itself. This is blatant practice for most herbals and appears to be unregulated. The label says

It is my contention that most people would interpret this label as a claim that the tablets would have a beneficial effect on the symptoms of "common cold and influenza type infections". The impression is reinforced by the government stamp of approval on the package.

The MHRA tell me that no tests have been done to discover how shoppers interpret these words. They should have been done.

Why is there nothing on the label that tells the plain, unvarnished truth? Perhaps something like this

"There is no evidence that this product works for the indications mentioned".

Or

"Clinical trials have shown this product to be ineffective for xxx "

or, at a minimum

"The MHRA kite mark does not imply that this product is effective".

Some Evidence

Echinacea is a generous choice of example because, unlike most herbs, there is a bit of evidence about its effectiveness. A Cochrane review says

Sixteen trials including a total of 22 comparisons of Echinacea preparations and a control group (19 placebo, 2 no treatment, 1 another herbal preparation) met the inclusion criteria. All trials except one were double-blinded. The majority had reasonable to good methodological quality. Three comparisons investigated prevention; 19 comparisons investigated treatment of colds. A variety of different Echinacea preparations were used. None of the prevention trials showed an effect over placebo. Comparing an Echinacea preparation with placebo as treatment, a significant effect was reported in nine comparisons, a trend in one, and no difference in six. Evidence from more than one trial was available only for preparations based on the aerial parts of Echinacea purpurea (E. purpurea).

“It seems that some preparations based on the herb of Echinacea purpurea might be effective for this purpose in adults, while there is no clear evidence that other preparations are effective or that children benefit. Side effects were infrequent but rashes were reported in one trial in children.”

The US agency NCCAM has spent over a billion dollars on testing various sorts of alternative treatment, and has failed to find a single useful treatment, They say

"Two NCCAM-funded studies did not find a benefit from echinacea, either as Echinacea purpurea fresh-pressed juice for treating colds in children, or as an unrefined mixture of Echinacea angustifolia root and Echinacea purpurea root and herb in adults."

So the evidence is a mess. There is no evidence that Echinacea can prevent colds, and, at the very best, it might shorten slightly the time for which cold symptoms last. The most likely interpretation of the mixture of contradictory results, many negative trials with a handful of small positive effects, is that for practical purposes, echinacea is useless. There is NO treatment known that affects the duration of a cold to any useful extent.

I wrote to Kent Woods in February 2011

Hello

Sorry to bother you again, but recent events have caused me to think about a rather fundamental question, and I have never seen it discussed in any official documents. I suspect it needs to be answered at the highest level.

Question, Do you make any distinction between (a) herbs that have unknown efficacy (most of them). and (b) herbs that have been shown in good trials to have no useful effect (like echinacea)?

It is one thing to say “traditionally used for …” when you don’t know whether it is true or not.

It is quite another thing to say “traditionally used for. . . ” when you know it is untrue

No such distinction seems to be made at the moment.

Is that because the distinction has never been considered by the MHRA?

Or is it because it has been considered, but dismissed as unimportant?

Or is it considered important but you are prevented from doing anything about it (and, if this is the case, what prevents you?)

Best wishes

David

His reply was, essentially, that herbs come in so many different forms that they can’t all be tested so it is never possible to say that a herb “does not work to any useful extent”

. . .

Based on our experience of regulating herbal medicines, we think it unlikely for the foreseeable future that there would be available for particular herbs a comprehensive body of published studies that meet medicines regulatory standards and cover systematically the numerous possible permutations as to type of extract, plant species and part of plant. Consequently, it is unlikely that evidence would be available for MHRA to know that a traditional herbal product did not have efficacy.

In summary, you suggest an interesting scenario the handling of which would be worthy of further consideration in the event of major advances in the range and quality of clinical trials of herbal medicines – but for the foreseeable future we would see the dilemma as largely a theoretical one.

Regards

Kent Woods

This strikes me as a cop-out. It amounts to saying that it’s impossible ever to say that a treatment us useless. If NICE took the same view, no medicine would ever be ruled out as having no useful effect.

"The growth of the THR scheme means that consumers will have access to a wide choice of over-the-counter herbal medicines made to assured standards.

"The current signs are that the market will be lively and competitive. The key difference for consumers is that in future they will be in the driving seat and able to make an informed choice when they wish to use these medicines.
"

Since the main sort of information that people want about a medicine is whether it works, and you have explicitly ruled out any information about that, the description "informed choice" seems to me to be exaggerated to the point of dishonesty.

This raises another question. Many people think that the wording that you approve is deceptive. can you tell me whether you have yet done tests to discover whether or not the average consumer interprets your wording as suggesting effectiveness? This was raised (apropos oh homeopathics) with Kent Woods at the SciTech enquiry and they were assured such tests had been done. Still nobody has seen the result of such tests. Please will you let me know if they have been done, and, if they have, what the results were? if they have not been done, why not?

Best regards
David Colquhoun

The legal requirement

In response to my letter, Richard Woodfield said

"Specifically on the question of wording affecting efficacy, we have to comply with the requirements of the herbals Directive which specifies the required product information about the traditional basis of the registration. We have not user tested the required statement in the Directive.
"

The European Herbals directive 2004/24/EC [download it] does make it mandatory to include the words used by the MHRA

“In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication( s) exclusively based upon long-standing use.”

Telling the truth on the label

I asked the MHRA whether there was any legal reason why they could not add the following notice to the wording required by the European Directive. I had to ask the question several times before I got a straight answer, but the answer eventually turned out to be that there is no legal reason that bars honest labels. Eventually Richard Woodfield told me there was no legal reason.

Dear Prof Colquhoun

There is no specific bar in the European Directive that would definitely preclude requiring additional statements that were consistent with the Directive. Obviously one would have to look at the specifics of what was proposed.

The main bar is that of Government policy. Under the previous Administration when the scheme was set up there was a strong policy of avoiding gold plating of European legislation – and this would clearly be a case of gold plating. Under the new Government that policy of avoiding gold plating has been strengthened further. And added to that there is now a presumption that wherever possible Directives should be transposed by “copy out” of the text rather than elaborating upon the requirements of the Directive.

The onus would be on those seeking gold plating to demonstrate that it was necessary. In the present absence of evidence of significant detriment under the THR scheme to consumers who for example choose to take a THR to help with a condition such as mild indigestion we have no present plans to propose the introduction of a form of retrospective gold plating of this legislation.

As recognised in your last email, I think that is about as far as we can usefully comment on the issue for the time being.

Regards

Richard Woodfield

So, at last we have the answer. And pretty pathetic it is. “Gold-plating” is a term that is used by the anti-European lobby to describe the process of not simply implementing European law but making it more strict that is essential. In this case, I would claim that making the label honest was the opposite of gold-plating, The European law is obviously designed to encourage the herbal industry by disguising the lack of evidence for the herbs. The MHRA should correct that deficiency but has declined to do so.

Safety

The herbal medicine business, especially the Chinese Traditional medicine, is riddled with impure, contaminated and sometimes lethally toxic rubbish. Of course it is right that the public should be protected from this. Probably it is a job that should be done by Trading Standards officers, but sadly they have shown themselves time and time again to be incompetent and unwilling to enforce the law when it comes to false health claims. The MHRA make a reasonably good job on this front, but that is no reason for them to endorse misleading labels. Statutory regulation by the HPC will do nothing to help: on the contrary it will endorse courses that teach dangerous nonsense.

The Herbal Medicines Advisory Committee

The MHRA’s Herbal Medicines Advisory Committee should have resisted this misleading labelling, but they do not seem to have not done so (it’s hard to tell because the published minutes are totally free of any useful information). The chairman of that committee is Professor Philip A Routledge OBE MB BS MD FRCP FRCPE. If I had been in his position, I would have resigned. I believe that he has let down honest science, and potentially endangered patients by not insisting on honest labels. I do hope that this was not a result of pressure from the Prince of Wales. We know he has lobbied Kent Woods and Philip Routledge. Incidentally, Routledge is president elect of the British Pharmacological Society. Quackery has crept in even there.

What can be done

There us no reason why, even now, the MHRA could not change the labels to something honest. I expect the government is pressing them to support the herbal industry, and big business usually wins over regulators (as with banks).

Freedom of choice by consumers was mentioned several times by the MHRA. That’s fine. Nobody wants to ban echinacea. The whole point of labels is to ensure that it is informed choice. Labels that mislead do not help anyone. They hurt the consumer and they are disastrous for the reputation for integrity of the MHRA.

We should keep up the pressure on the MHRA. Here are a couple of my recent efforts, on BBC Breakfast TV.

The second interview was joint with Dick Middleton. It should have been made clear that Middleton is a pharmacist who is technical director of Schwabe Pharma, a company that sells expensive herbal pills, so has a vested financial interest in disguising the lack of evidence for efficacy,

Follow-up

1 May 2011. The new herbal regulations have come into effect. Radio 5 put me up against the herbal industry representative, Michael McIntyre (chair of the European Herbal & Traditional Medicine Practitioners Association). I was pleased to get the chance to debate directly with him, because he has been misrpresenting the evidence for years. See, for example, Some truly appalling reporting of science by the BBC. and Government lends credibility to quacks and charlatans. I was able, at last, to ask him directly, which herb had the best evidence for its efficacy. He repeatedly refused to answer: “I’m not going to get into detail”. Eventually he resorted to the argument that herbalists treat people not diseases. I pointed out that the MHRA-approved labels list all sorts of diseases. No response. He then misquotes Sackett, who did NOT say that experience was as good as RCTs.

McIntyre goes on to misrepresent the BMJ Clinical Evidence paper which, he says, shows that 46% of all treatments are not proven to be effective. It is hard to be believe that McIntyre is really unaware that a large proportion of those that were not shown to be effective are CAM treatments, herbal medicine and the like. Professor John Garrow has pointed this out (see, also Healthwatch). Either he doesn’t read the literature or he deliberately misrepresents it.

Then a caller came in to swear that Chinese Medicine had cured his prostate problem and his wife’s hair. Of course he hadn’t any idea of how is prostate would have progressed if he hadn’t taken the Chinese medicine. Luckily for him, he didn’t have prostate cancer (the people who take Chinese medicine for cancer are probably dead so they can’t appear on the radio). These people are difficult to deal with without appearing rude, by saying they are gullible and deceived. I tried. Interestingly McIntyre did not leap to the defence of Chinese herbs.

The DH report is merely an analysis of responses to the consultation, but the MHRA says

"The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients."

The MHRA points out that this started 11 years ago with the publication of the House of Lords report (2000). Both that report, and the government’s response to it, set the following priorities. Both state clearly

“… we recommend that three important questions should be addressed in the following order . .

(1) does the treatment offer therapeutic benefits greater than placebo?

(2) is the treatment safe?

(3) how does it compare, in medical outcome and cost-effectiveness, with other forms of treatment?

The report of DH and the MHRA’s response have ignored totally two of these three requirements. There is no consideration whatsoever of whether treatments work better than placebo (point one) and there is no consideration whatsoever of cost-effectiveness (point 3). These two important recommendations in the Houss of Lords report have simply been brushed under the carpet.

Needless to say, herbalists are head over heels with joy at this sign of official endorsement (here is one reaction)

Here are my first reactions. The post will be updated soon.

The DH report is, in a sense, democratic. They have simply counted the responses, for and against each proposal. They seem to be quite unaware that most of the responses come from High Street herbailsts whose main aim is to gain respectability. The response of the Academy of Royal Medical Colleges counts as one vote, just the same as the owner of a Chinese medicine shop. This is not how health policy should be determined. Some intervention of the brain is needed, but that isn’t apparent in the report.

At present the HPC regulates Arts therapists, biomedical scientists, chiropodists/podiatrists, clinical scientists, dietitians, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, prosthetists/orthotists, radiographers and speech & language therapists. I shudder to think what all these good people will think about being lumped together with people who practice evidence-free medicine (or, worse, forms of medicine where there is good evidence that they don’t work).

The vast majority of herbalists, traditional Chinese medicine (TCM) and acupuncture has no good evidence that it works, In the case of soem herbal medicines and acupuncture, there is good evidence that they don’t work. Yet the HPC has, as one of its criteria, that aspiring to be regulated by them requires

Another mistake made by the Department of Health regards the value of "training". The report (page 11) says

Would statutory regulation lessen the risk of harm? (Q2)
Again, the vast majority of respondents thought it would. Reasons given were that statutory regulation would ensure that herbal practitioners and acupuncturists are carefully and thoroughly trained. That training is subject to accreditation, evaluation and periodic review by independent educational and training professionals, and disciplinary oversight by a regulating body. Incompetent or unscrupulous practitioners could be struck off the register and prevented from practising.

Although it is pointed out to them in several responses, the Department of Health seems quite incapable of understanding a simple and obvious truth. Spending three years training people to learn things that are not true, safeguards nobody. On the contrary, it endangers the public. Training in nonsense is obviously a nonsense.

At the end of the report is a list of organisations who responded, As expected, they are predominantly trade bodies that have a vested interest in allowing thinks to be sold freely regardless of whether they work or not. The first four are Alliance of Herbal Medicine Practitioners. European herbal and Traditional Medicine Practitioners Association (ETMPA), Association Chinese Medicine Practitioners (UK) (ACMP) and Acupuncture Society. And so on.

More coming soon.

Follow-up

16 February 2011. Later the same day, we see one reason why Michael Mcintyre, chair of the European Herbal Practitioners Association, got what he wanted to promote his trade. They had evidently hired a PR Agency, Cogitamus, to push their case. Now they are crowing about their victory. And of course his profits were not harmed by the free publicity that was given to his cause by the BBC,

The pinheads in the Department of Health are more easily persuaded by a PR agency than by any number of people who know a lot more about it, and who have no profit motive.

The Metro article elicited a fine bit of abuse from a Lynda Kane. I’m constantly amazed at the downright viciousness of cuddly holistic therapists when they get found out. I guess it is just another bad case of cognitive dissonance. I can’t resist a few quotations.

“As a scientist myself, I abide by the virtues of open-minded neutrality and accepting the hypothesis until proven otherwise by null-hypothesis based research.”

“How many of the innumerable studies on the efficacy of herbal medicine have you read? “

“Perhaps in your ‘day’ professors could say whatever they liked and be listened to. That day is long gone, as you must know from the various law-suits you have been party to.”

I love the idea that statistics allow you to accept any hypothesis whatsoever until someone shows it to be wrong.

This would be funny if it were not so sad (and rather painful). As always I replied politely and referred her to NCCAM’s Guide to Herbs, so she can check up on that plethora of evidence that she seems to think exists.

This is Lynda Kane of energyawareness.org. I can recommend her web site, if you want some truly jaw-dropping woo. She’ll sell you a “White Jade Energy Egg – may provide up to 5 times as much protection from wifi and from other peoples’ energies – costs £47.00”. Hmm, sounds good. How does it work? Easy.

“The human energy or “qi” field is shaped like an egg. It is being attacked by many forms of natural and man-made environmental stress 24 hours a day.”

I guess that’s OK according to Ms Kane’s interpretation of statistics which allows you to accept any hypothesis whatsoever until someone shows it to be wrong.

Nothing visible happened after this announcement. Until the government’s resident medical loon, David Tredinnick MP forced a debate on the matter. His introduction to the debate was his usual make-believe. Sadly it made much of an exhibit at the Royal Society Summer Science exhibition -a bit of bait and swich by aromatherapists.

After ploughing your way through pages of nonsense, you get to the interesting bit. At 10.38 am, The Parliamentary Under-Secretary of State for Health, Dr Daniel Poulter, announced what was happening. It seems that there may, after all, have been some effect of all the sensible submissions which pointed out the impossibility of regulating nonsense. The question of regulation has, yet again, been postponed.

"To ensure that we take forward the matter effectively, we want to bring together experts and interested parties from all sides of the debate to form a working group that will gather evidence and consider all the viable options in more detail,"

One wonders who will be on this working group? If they don’t choose the right people, it could be as bad as the Pittilo report. It wasn’t reassuring to read

" we want to set up a working group and to work with my hon. Friend [Tredinnick], and herbalists and others, to ensure that the legislation is fit for purpose."

I hate to be forced to return to the world’s most boring delusion, homeopathy. It is boring because the battle to inform people how daft it is has been almost won. Now not a single Bachelors degree in homeopathy appears in UCAS, compared with at least five in 2007. But the battle is not quite won with the UK Government. This post is not so much about homeopathy as about the failures of the Government and the MHRA.

The Medicines and Health Regulatory Authority (MHRA), has just launched yet another consultation and I have felt obliged to waste an entire Sunday writing a response to it, I can’t imagine that any scientist would disagree much with what I have written, but most of them have far better ways to spend their time than bothering about the lunatic fringes of medicine. No doubt most of the responses will come from people who make money from homeopathy, Not just the homeopaths on the High Street, but also the very rich companies like Boiron and Weleda who make enormous profits from selling pills that contain nothing but a bit of sugar.

The documents

The consultation concerns what should be done, about homeopathy in the wake of the scarifying report of the House of Commons Select Committee [get pdf], and the governments response to that report [get pdf].

Now I’ll filll in some of the background and outline why I think the MHRA still hasn’t understood.

The Medicines Act 1968 and PLRs

The Medicines Act (1968) was passed in the wake of the thalidomide disaster. It required evidence that medicines work and that they are safe. It was not possible to check all existing medicines by the time the Act was implemented in 1971, so, as a temporary measure, many medicines, including homeopathic stuff, were give a "public licence of right" (PLR). Forty years later they have mostly vanished. But not for homeopathy. The PLR is the licence that allows homeopaths to break all the rules. They still exist.

MHRA cocked it up in 2006

The story starts with the National Regulation Scheme for homeopathic junk that was introduced by the MHRA in 2006. This allowed, for the first time, indications to be put on the labels of the bottles of sugar pills. There were howls of outrage from just about every scientific organisation (the medical establishment was, as usual, more pusillanimous, with some honourable exceptions). The history is related here in the following posts.

This was an admirable effort, It extracted, with some difficulty, admissions from Boots’ professional standards director that the sold pills while knowing that they didn’t work. It also squeezed out of the then Health Minister, Mike O’Brien an admission that they don’t work, Less surprisingly, the head of the MHRA agreed that they don’t work. So it is unanimous (apart, of course, from those who make money from selling things that don’t work).

The Government’s response to the report was mostly as truly pathetic bit of official waffle, like those letters you get when you write to your Member of Parliament. But it did contain one good thing."In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available." (though even that statement is attributed to John Beddington, the Government’s Chief Scientific advisor, rather than something the Government thinks essential).

"“The MHRA will review the labelling requirements under the NRS to ensure that these deliver clarity as to the status of products and their composition."

The proposals in the MHRA Consultation document’

There are a couple of good things in the proposals. The MHRA proposes to end PLRs (decades overdue, but nonetheless welcome).

The MHRA proposes to stop ‘regulating’ (ho ho) “Bach Flower Remedies” as medicines (but seems happy to classify them as food Supplements, another weasel description to evade sensible regulation). That’s sensible because they aren’t medicines. Homeopathic pills most certainly aren’t medicines either but the MHRA seems to have difficulty grasping that, and wants to treat them quite differently from “Flower remedies”

More honest labelling was about the only sensible thing recommended by the Government’s response. On this topic the MHRA proposals verge on the laughable

At present the labelling allowed under the NRS includes

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of ….”

It is proposed to change this to

“A homeopathic medicinal product licensed only on the basis of safety, quality and use within the homeopathic tradition”

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of……”

Spot the difference!

The is utterly inadequate. In fact it verges on the pathetic (and on the dishonest). Here is an extract from my full response.

"Sad to say these proposals to remedy the labelling problem are wholly inadequate. They are almost as deceptive as the originals. These labels don‘t come anywhere near to fulfilling the requirement in the government‘s response which said

In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available

Why, oh why, cannot the MHRA bring itself to simply tell the truth? It seems to be so stifled by some perversion of political correctness that it is unable to do what it must know is right.

The MHRA must decide whether or not it believes Avogadro‘s number or not.

How many people in the general public realise the ―Each pill contains 30C Arnica Montana‖ means that the ―pills contain no Arnica whatsoever‖? The very mention of the words ―active ingredient‖ will suggest to most people that there is an active ingredient when there is not. This wording alone is both dishonest and deceptive.

The rest of the approved label consists largely of make-believe too.

"If you are pregnant or breastfeeding consult your doctor before use"

What is your doctor meant to advise you about the dangers of taking a few mg of sugar when you are pregnant?

"If you take too much of the product (overdose) speak to a doctor / pharmacist and take this label with you,."

Unless the MHRA has disavowed Avogadro‘s number, an overdose is impossible. To allow a label like this makes the MHRA a laughing stock

http://www.dcscience.net/wp-admin/edit-tags.php?taxonomy=category

Labels should tell the truth in plain language. For example they should say

This product contains no Arnica

There is no evidence that it works for any condition, other than as a placebo

Some comments on regulation of magic medicine

Governments like to regulate things. They should have regulated the banks a bit more. The problem arises when you try to regulate things that are myths. Like homeopathy.

The government appears to believe that "training" will solve all the problems. Training people to believe things that aren’t true can never solve problems. On the contrary, it creates problems. Organisations like the Complementary and Natural Health Care Council (CNHC)do nothing to protect the public, They endanger the public (see Why the CNHC can’t succeed). Their excuse for rejecting complaints that members were making false claims was not to deny that the claims were false, but to say that it didn’t matter because that is what they had been trained to say. That is make-believe regulation.

Follow-up

News today makes one despair of the morality of governments. Remember those obviously fraudulent bomb detectors, no more than a dowsing rod? Although they are now the subject of a fraud investigation, they are still being sold. The government has banned their export to Iraq and Afghanistan, but NOT to anywhere else, This suggests not only that the government is (or at least was) quite happy to believe in dowsing. It also implies that even when they realise that it’s fraud they take the view that that business is far more important than even the most basic morality. No doubt they will allow fraudulent labelling of medicines in order to protect the homeopathic industry

Yesterday I was fired from the Conduct and Competence Committee of the CNHC. That is the organisation that was very quickly dubbed Ofquack in the blogosphere. So now I am free to write what I like about about it.

It has now become clear that voluntary self-regulation can not work. Recent events at the CNHC show how it has become a victim of its own rules [skip the background].

Background

The CNHC was the product of the late unlamented Prince of Wales’ Foundation for Integrated Health. The Prince’s Foundation was paid a large amount of taxpayers’ money, £900,000, by the Department of Health to come up with a scheme for voluntary self-regulation of various sorts of alternative medicine.

There is, as usual, an enormous amount of relevant information can be found on the ebm-first site.

“What won’t work is to insist that homeopaths are “properly trained”. If one takes the view that medicines that contain no medicine can’t work, then years of being trained to say that they do work, and years spent memorizing the early 19th century mumbo-jumbo of homeopathy, does not protect the public, it imperils them.”

On 25 September 2008, someone sent me an advertisement for a job on the conduct and competence committee. The job description seemed to fit me quite well, so I applied. I presumed they wouldn’t take me, and then I could write a blog about it. But after a phone interview with co-chair Maggy Wallace, I was amazed to be offered the job.

Since joining them I haven’t actually done anything whatsoever, apart from offering a few general ideas, because no cases have actually reached the Conduct and Competence Committee.

This was the first time I had encountered a quango at first hand. Several of the members seemed to have no great interest in medicine, or even in alternative medicine. They were more interested in regulation per se, or at least the sort of pseudo-regulation that most of these bodies mostly seem to offer. They seem to suffer from the well-known delusion that you can manage/regulate something without knowing anything about it. In cases such as this one, where what is being regulated is largely nonsense, there are bound to be problems.

There were two people, whom I did come to like particularly, Maggy Wallace and John Lant. They were both willing to talk and to listen.

The anonymous emails

The alternative medicine community took a surprisingly long time to notice my presence, but on 19 May 2010 a pretty vicious anonymous email arrived at the CNHC, complaining about me. Here it is.

Nutritional therapy self-styled ‘nutritionists’; making untrue claims about diet in order to sell you unnecessary supplements.

Reiki: tea and sympathy, accompanied by arm-waving.

Shiatsu uh? It seems the teacher is already committed to placebo medicine.

[All the above quotes; and many more stated by David Colquhoun, CNHC Panel member]

Contents

1: Colquhoun and CNHC

2: More statements from Colquhoun

3: Want some more!!!

4: What to do

1. Colquhoun and CNHC

Colquhoun is a man who has steadfastly attacked, denigrated and taken all steps he can to undermine those involved in natural health. Yet Colquhoun is now (and has been for more than a year) a member of the CNHC’s Conduct and Competence Committee.

The role of CNHC is to regulate the professions of their members. But what is the rational behind allowing an avowed critic of natural medicine onto the Conduct and Competence Committee. Isn’t this like asking racist to be objective about the circumstances of racist crime?

Would you, as a practitioner having to answer to a complaint, be happy to have one of the panel members think your profession is ‘bollocks’ or that everything you practice is fraudulent from the start?

Latest moves from the government now aim at putting all Herbal Practitioners under the authority of CNHC.

Do you want your personal and confidential data, and that of your patient/client in the hands of Colquhoun? What might happen to it?

Certainly every practitioner has to be responsible for their actions and practice but since when has it been standard practice to weigh the scales against you rather than be assessed by a panel of independent peers?

* Acupuncture: a rather theatrical placebo, with no real therapeutic benefit in most if not all cases.

So what kind of organisation is CNHC and why have they put him on to their Conduct and Competence panel? Being a CNHC member seems to be like inflicting pain on yourself.

CNHC also received funding from the Prince’s Foundation for Integrated Health (FIH). Yet Colquhoun regularly lambasts the FIH and Prince Charles himself categorizing him as a ‘champion of endarkenment’ [http://www.dcscience.net/?p=2544] and calling the FIH the Foundation Fellows of the Prince of Wales Foundation for Magic Medicine, an organisation that is at the forefront of spreading medical misinformation. [http://www.dcscience.net/?p=2131]

Of course, no one expects that because an organisation provides funding it should be exempt from criticism but surely, if you are working for an organisation whose purpose is to represent standards in a certain field, why would you have someone on your management team who fires out carping criticism at the supporting organisation, its practitioners and its practices unless perhaps, it is your purpose to spread discord and cut the funding.

No wonder the CNHC has problems. Their business plan (contingent on funding) was initially to have more than 10,000 enrolled members. This has been revised down to 2,000 and by all counts they have not even made this. Not surprising if the practitioners whom you represent don’t have any trust in the organisation that is supposed to represent the standards of your profession.

It is interesting to compare the high standards of the Nutrition Society with the quite different standards of BANT (the British Association for Applied Nutrition and Nutritional Therapy).& They bill themselves as the “Professional Body for Nutritional Therapists”. Nutritional therapists are those fantasists who believe you can cure any ill by buying some supplement pills. [http://www.dcscience.net/?p=1391]

[On quotes taken from Nutritional Therapy text] That must be about as close as you can get to claiming you can prevent cancer by taking vitamin pills. It is wrong and t is dangerous,

Everyone is for good nutrition of course, but ‘nutritional medicine’, or ‘nutritional therapy’ pretends to be able to cure all sorts of diseases by changes in diet or by buying expensive nutritional supplement pills. It has no perceptible relationship to the very important subjects of ‘nutrition’ or ‘dietetics’.. ‘Nutritional therapy’ is very firmly part of alternative medicine, in other words it is largely quackery. If you don’t believe that, read on. http://www.dcscience.net/?p=260

On Reflexology

As usual, not many seemed to care very much about the secondary consequences of employing a ‘reflexologist’, namely that some poor kid has to memorise a bunch of lies to get the piece of paper demanded by HR (and the taxpayer has to fund it). http://www.dcscience.net/?page_id=237

What is the evidence about ‘spiritual healing’ ? Very little it seems.

No doubt, mumbo-jumbo can make some people feel better, and to that extent it is justified. But it can and should done be honestly (for example, foot massage is fine, ‘reflexology’ isn’t). Lies to patients should be minimised and universities should not be tempted to hand out certificates in mumbo jumbo. http://www.dcscience.net/?p=34

Michael McIntyre has the first of several long speeches, advocating more research. There was an advertisement for his web site “promotes best practice” (allegedly). He talks quite seriously about “reflexology” and so on, as though it were real subject (it isn’t; its “principles” are made-up fantasies). http://www.dcscience.net/?p=2813

Much of what they do at the Christie is straightforward massage, but they also promote the nonsensical principles of ‘reflexology’ and acupuncture. http://www.dcscience.net/?p=1466

The hilarious Radio 4 programme, The News Quiz had a good joke. Jeremy Hardy was asked which patients are hoping for a more robust constitution?. This referred to the £1m PR exercise mounted by the NHS to launch the NHS constitution. Hardy said that in the week when Barack Obama was inaugurated, and the word constitution have a whole different sort of gravitas in a week like that.

Why join an association that condones the above? Many have never joined CNHC because of this and other issues whilst existing CNHC members do not want to remain members.

1. Contact your professional association and insist that they do not join CNHC.

2. If your association is already a member then make a complaint and insist that your personal details are not supplied to CNHC.

3. There are other associations in existence that have the same purpose as CNHC. Find out about them. You (or your professional association) have the option to join them and
be represented by/answerable to them. CNHC is not the only option and one should wonder why they were chosen in the first place.

4. Please pass on this information to anyone else that you know. It is important that we are represented honestly and with integrity. The actions of CNHC do not add up.

ooOOoo

Nobody seems to know the real name of Sara Glougan (aka Sam McGlougan. The letter is, I suppose, fair enough. I did say most of those things. What’s objectionable is that the anonymous writer seems to think that my opinions disqualify me from judging dispassionately a Conduct and Competence case. What this letter really says is that "we don’t want anyone who cares about the truth of claims to have any power over us". They just don’t want to be regulated in any effective way. The co-chair, Maggy Wallace, is a bit more sensible than that. The reason that I was appointed by her was because of my knowledge about how to assess evidence. But that isn’t a topic that interests alternative medicine advocates.

The fact of the matter is that the CNHC has been signing up people at a far slower rate than it hoped originally. It is in dire financial trouble (see, for example, Will the government bail out Ofquack?>, and CNHC’s report to the Department of Health in June 2009, obtained under the Freedom of Information Act.. The last thing they can afford is anything like this letter, which might reduce the registration rate still further. So it was inevitable that they had to get rid of me. Initially I was invited to resign on grounds of bad health. I didn’t, so on 10 August 2010 I was asked to appear before the board to be fired (in the nicest possible way). The CNHC now has nobody with any statistical expertise. Needless to say I’m not heartbroken about it. It was a waste of time for me, but it did provide a valuable insight into how voluntary self-regulation works, or rather fails to work.

“The ad suggests that reflexology is suitable for treating babies with colic, IBS and arthritis. She also claims to have experience in treating fertility issues. There is no reliable evidence to suggest that reflexology is capable of treating [these] issues.”

This complaint never came to to the Conduct and Competence Committee. It didn’t get past the preliminary Investigating Committee (chaired by John Lant), the job of which is to see if there is a case to answer. They decided that the advertisements in question did indeed breach paragraph 15 of the CNHC’s Code of Conduct, Performance and Ethics (see below). All 14 of Simon Perry’s complaints were upheld. However the Investigating Committee Panel’s report went on to say, apparently on the advice of the ‘Profession specific boards’ that

“The ICP found that the registrants’ Fitness to Practise was not impaired, because they did not deliberately seek to mislead their clients or to exaggerate the benefits of the therapy which they described in good faith. However they found that the registrants had made claims about the therapy offered which appeared to imply more efficacy than evidence necessarily provides.”

That, presumably, is why the complaints never reached the Conduct and Competence Committee. There was no case to answer.

One must admire Maggy Wallace’s statement that she “place on formal record their thanks to Simon Perry for bringing this matter to their attention.”. Never the less the problem is glaringly obvious and it shouldn’t have need a complaint.

Why ofquack can never work

The complaint episode is fascinating. The CNHC has clearly painted itself into a corner. It has brought to the fore all the contradictions that are inherent in what they are trying to do.

They have decided that reflexologists make false claims about what they can achieve.

But they decided it wasn’t the fault of the reflexologists because that is what they had been taught

Therefore the CNHC has judged that fitness of reflexologists to practise is not affected by the fact that they make false health claims.

That means that the CNHC judges that the public safety is not affected by whether their members make false health claims. That seems ludicrous enough, but it goes further

In the initial publicity it was often said that the job of the CNHC was safety -their job to protect the public, not to judge whether treatments worked or not. That sort of statement is contradicted directly by paragraph 15 of their Code of Conduct, Performance and Ethics, which reads thus.

15. You must follow CNHC guidelines in relation to advertising your services

Any advertising you undertake in relation to your professional activities must be accurate. Advertisements must not be misleading, false, unfair or exaggerated. You must not claim that your personal skills, equipment or facilities are better than anyone else’s.

If you are involved in advertising or promoting any other product or service, you must make sure that you use your knowledge, healthcare skills, qualifications and experience in an accurate and professionally responsible way. You must not make or support unjustifiable statements relating to particular products or services. Any potential financial rewards to you should be made explicit and play no part at all in your advice or recommendations of products and services that you give to patients, clients and users.

This paragraph places on the CNHC the responsibility for judging whether or not a treatment does what’s claimed for it. With my departure, there is really nobody left who is well-qualified to do that,
but nonetheless, their judgement on claims made by reflexologists was quite right.

The assertion by the CNHC that the false claims were OK because that is what reflexologists are taught is a direct admission that the courses that ‘train’ reflexologists are teaching them to say things that are not true. Of course the rest of the world knew that already, but to have it admitted by the CNHC is amazing.

Part of the job of the CNHC is to judge whether registrants are properly trained. But they have just decided that courses for reflexologists teach them to say things that aren’t true, That leaves the CNHC it an impossible position. By accepting reflexologists, they are saying that it doesn’t really matter that they are taught to make false claims, The criteria for entry include

“Have undertaken a programme of education and training which meets, as a minimum, the National Occupational Standards for that profession/discipline”

This shifts the responsibility for deciding what’s acceptable to National Occupational Standards and Skills for Health. Neither of these quangos is in the least concerned about what’s true and what isn’t. That’s not surprising when you realise who drafted all the HR style nonsense to be found at Skills for Health? None other than the late Prince of Wales’ Foundation. The stuff produced by them isn’t worth the paper it’s written on. There is something about Skills for Health in the post where I recount a phone call with them, When I asked whether they would produce standards for talking to trees, I was referred, in all seriousness, to LANTRA, the Land based skills council. You couldn’t make it up.

Reflexology is the study and practice of treating reflex points and areas in the feet and hands that relate to corresponding parts of the body. Using precise hand and finger techniques a reflexologist can improve circulation, induce relaxation and enable homeostasis. These three outcomes can activate the body’s own healing systems to heal and prevent ill health.

There is, if course, not a shred of reason to think that “areas in the feet and hands that relate to corresponding parts of the body”. This statement alone would fail the CNHC’s code of conduct. National Occupational Standards in this area are simply a farce.

What will the CNHC do about these paradoxes? The complaint report said

“The ICP have asked Maggie Dunn, the CNHC Registrar, to initiate, as a matter of priority, discussions with the CNHC’s Profession Specific Boards and the Professional Fora to agree advice to registrants in relation to paragraph 15.”

I was told that this might take between 3 and 5 years to do. But I have a strong feeling that it will never be done in any effective way. If the CNHC prevented training courses from teaching students to make claims that aren’t justified by evidence, just about every course would close and the CNHC would crumble to dust. The result would be the ultimate irony. Alternative medicine would be abolished, not by skeptics, but by the CNHC.

That follows inevitably from the complaint judgement combined with paragraph 15 of the code of conduct.

It will be fascinating to see how the CNHC tries to escape from the grave that it has dug for itself.

If the CNHC implements properly its own code of conduct, few people will sign up and CNHC will die. If it fails to implement its own code of conduct it would be shown to be a dishonest sham.

I’ve had permission to post a submission that has been sent to the Pittilo consultation. The whole document can be downloaded here. I have removed the name of the author. It is written by the person who has made some excellent contributions to this blog under the pseudonym "Allo V Psycho".

The document is a model of clarity, and it ends with constructive suggestions for forms of regulation that will, unlike the Pittilo proposals, really protect patients

Here is the summary. The full document explains each point in detail.

Executive Summary
Statutory regulation lends prestige, but needs to be balanced by a requirement for practitioners to be competent, as is the case for doctors and nurses. Regulation almost exclusively deals with conduct, but the unique risks posed by alternative medicine are not addressed by this. The harms which will arise from licensing practitioners who are not required to show evidence of competence and efficacy are:

Harm 1. Misdiagnosis of serious conditions. Alternative practitioners offer to diagnose illnesses without proper training. This can lead to avoidable death, such as treating an ectopic pregnancy with ginger.

Harm 2. Withdrawal from treatment. Clients of alternative practitioners risk being encouraged to withdraw from life saving treatments in favours of treatments without evidence, as in the death of baby Gloria Thomas.

Harm 3. Harms arising from the nature of the alternative practice, but not covered by the regulatory framework, such as adulterated herbal remedies.

Harm 4. Lack of informed consent. If alternative practitioners are not required to study or show evidence of efficacy, how can they inform patients of their options?

Harm 5. Equity. Doctors and nurses have to use evidence based methods, but it is proposed that alternative practitioners are not held to this standard. Is this fair? Health Minsters should ask themselves if they advocate withdrawing the requirement for evidence based treatment from doctors and nurses. If not, why not? And if not, why should alternative practitioners be treated differently?

Harm 6. Promotion of irrationality. If no evidence of efficacy is required, where do you draw the line? Witch doctoring is a ‘traditional practice’ in communities in the UK, and astrology is used by some herbal healers.

Harm 7. Opportunity Costs. If no evidence of efficacy is required of alternative medicine, significant sums will be wasted by individuals and by the NHS.

Harm 8. Reputational harms for UK Higher Education. UK Honours Degrees are based on the ability to think critically and to assess evidence. Alternative medicine Degree programmes do not require this. These positions are not compatible.

Harm 9. Health care futures. We are making slow but steady progress on health indicators through the use of evidence based methods. Why should the requirement for evidence be abandoned now?

Instead, safe regulation of alternative practitioners should be through:

A new Health Advertising Standards Authority, modelled on the successful Cancer Act 1939.

The first two recommendations for effective regulation are much the same as mine, but the the third one is interesting. The problem with the Cancer Act (1939), and with the Unfair Trading regulations, is that they are applied very erratically. They are the responsibility of local Trading Standards offices, who have, as a rule, neither the expertise nor the time to enforce them effectively. A Health Advertising Standards Authority could perhaps take over the role of enforcing existing laws. But it should be an authority with teeth. It should have the ability to prosecute. The existing Advertising Standards Authority produces, on the whole, excellent judgements but it is quite ineffective because it can do very little.

A letter from an acupuncturist

I had a remarkable letter recently from someone who actually practises acupuncture. Here are some extracts.

“I very much enjoy reading your Improbable Science blog. It’s great to see good old-fashioned logic being applied incisively to the murk and spin that passes for government “thinking” these days.”

“It’s interesting that the British Acupuncture Council are in favour of statutory regulation. The reason is, as you have pointed out, that this will confer a respectability on them, and will be used as a lever to try to get NHS funding for acupuncture. Indeed, the BAcC’s mission statement includes a line “To contribute to the development of healthcare policy both now and in the future”, which is a huge joke when they clearly haven’t got the remotest idea about the issues involved.”

“Before anything is decided on statutory regulation, the British Acupuncture Council is trying to get a Royal Charter. If this is achieved, it will be seen as a significant boost to their respectability and, by implication, the validity of state-funded acupuncture. The argument will be that if Physios and O.T.s are Chartered and safe to work in the NHS, then why should Chartered Acupuncturists be treated differently? A postal vote of 2,700 BAcC members is under-way now and they are being urged to vote “yes”. The fact that the Privy Council are even considering it, is surprising when the BAcC does not even meet the requirement that the institution should have a minimum of 5000 members (http://www.privy-council.org.uk/output/Page45.asp). Chartered status is seen as a significant stepping-stone in strengthening their negotiating hand in the run-up to statutory regulation.”

“Whatever the efficacy of acupuncture, I would hate to see scarce NHS resources spent on well-meaning, but frequently gormless acupuncturists when there’s no money for the increasing costs of medical technology or proven life-saving pharmaceuticals.”

“The fact that universities are handing out a science degree in acupuncture is a testament to how devalued tertiary education has become since my day. An acupuncture degree cannot be called “scientific” in any normal sense of the term. The truth is that most acupuncturists have a poor understanding of the form of TCM taught in P.R.China, and hang on to a confused grasp of oriental concepts mixed in with a bit of New Age philosophy and trendy nutritional/life-coach advice that you see trotted out by journalists in the women’s weeklies. This casual eclectic approach is accompanied by a complete lack of intellectual rigour.

My view is that acupuncturists might help people who have not been helped by NHS interventions, but, in my experience, it has very little to do with the application of a proven set of clinical principles (alternative or otherwise). Some patients experience remission of symptoms and I’m sure that is, in part, bound up with the psychosomatic effects of good listening, and non-judgemental kindness. In that respect, the woolly-minded thinking of most traditional acupuncturists doesn’t really matter, they’re relatively harmless and well-meaning, a bit like hair-dressers. But just because you trust your hairdresser, it doesn’t mean hairdressers deserve the Privy Council’s Royal Charter or that they need to be regulated by the government because their clients are somehow supposedly “vulnerable”.”

It is described as being the “Report of an independent advisory group”. I guess everyone knows by now that an “expert report” can be produced to back any view whatsoever simply by choosing the right “experts”, so the first things one does is to see who wrote it. Here they are.

Professor Richard Lilford, Head of School of Health and Population Sciences, University of Birmingham

We see at once two of the best known apologists for alternative medicine, George Lewith (who has appeared here more than once) and Stephen Holgate.

Harry Cayton is CEO of Council for Healthcare Regulatory Excellence (CHRE) which must be one of the most useless box-ticking quangos in existence. It was the CHRE that praised the General Chiropractic Council (GCC) for the quality of its work. That is the same GCC that is at present trying to cope with 600 or so complaints about the people it is supposed to regulate (not to mention a vast number of complaints to Trading Standards Offices). The GCC must be the prime example of the folly of giving government endorsement to things that don’t work. But the CHRE were not smart enough to spot that little problem. No doubt Mr Cayton did good work for the Alzheimer’s Society. His advocacy of patient’s choice may have helped me personally. But it isn’t obvious to me that he is the least qualified to express an opinion on research methods in anything whatsoever. According to the Guardian he is “BA in English and linguistics from the University of Ulster; diploma in anthropology from the University of Durham; B Phil in philosophy of education from the University of Newcastle.”

Adrian Eddlestone is a retired Professor of Medicine. He has been in academic administration since 1983. His sympathy for alternative medicine is demonstrated by the fact that he is also Chair of the General Osteopathic Council, yet another “regulator” that has done nothing to protect the public
from false health claims (and which may, soon, find itself in the same sort of trouble as the GCC).

I shall refer here to ‘alternative medicine’ rather than ‘complementary medicine’ which is used in the report. It is not right to refer to a treatment as ‘complementary’ until such time as it has been shown to work. The term ‘complementary’ is a euphemism that, like ‘integrative’, is standard among alternative medicine advocates whose greatest wish is to gain respectability.

The Report

The recommendations

On page 10 we find a summary of the conclusions.

The report identifies five areas of consensus, which together set a framework for moving forward. These are:

the primary importance of controlled trials to assess clinical and cost effectiveness.

the importance of understanding how an intervention works

the value of placebo or non-specific effects

the need for investment and collaboration in creating a sound evidence base

the potential for whole-system evaluation to guide decision-making and subsequent research.

The first recommendation is just great. The rest sound to me like the usual excuses for incorporating ineffective treatments into medical practice. Notice the implicit assumption in the fourth point
that spending money on research will establish “a sound evidence base". There is a precedent, but it is ignored. A huge omission from the report is that it fails to mention anywhere that a lot of research has already been done.

As happens so often, there is implicit in this sentence the assumption that if you spend enough money evidence will emerge. That is precisely contrary to the experence in the USA where spending a billion dollars produced nothing beyond showing that a lot of things we already thought didn’t work were indeed ineffective.

“It is noteworthy that the evidence is now sufficiently robust for NICE to include acupuncture as a treatment for low back pain.” [p ]

Did the advisory group not read the evidence used (and misinterpeted) by NICE? It seems not. Did the advisory group not read the outcome of NIH-funded studies on acupuncture as summarised by Barker Bausell in his book, Snake Oil Science? Apparently not. It’s hard to know because the report has no references.

George Lewith is quoted [p. 15] as saying “to starve the system of more knowledge means we will continue to make bad decisions”. No doubt he’d like more money for research, but if a billion dollars
in the USA gets no useful result, is Lewith really likely to do better?

The usual weasel words of the alternative medicine industry are there in abundance

“First, complementary practice often encompasses an intervention (physical treatment or manipulation) as well as the context for that intervention. Context in this setting means both the physical setting for the delivery of care and the therapeutic relationship between practitioner and patient.” [p. 12]

Yes, but ALL medicine involves the context of the treatment. This is no different whether the medicine is alternative or real. The context (or placebo) effect comes as an extra bonus with any sort of treatment.

“We need to acknowledge that much of complementary practice seeks to integrate the positive aspects of placebo and that it needs to be viewed as an integral part of the treatment rather than an aspect that should be isolated and discounted.” [p. 13]

“. . . we recommend that three important questions should be addressed in the following order”. (1) does the treatment offer therapeutic benefits greater than placebo? (2) is the treatment safe? (3) how does it compare, in medical outcome and cost-effectiveness, with other forms of treatment?.

The crunch comes when the report gets to what we should pay for.

“Should we be prepared to pay for the so-called placebo effect?

The view of the advisory group is that it is appropriate to pay for true placebo (rather than regression to the mean or temporal effects).” [p 24]

Perhaps so, but there is very little discussion of the emormous ethical questions:that this opinion raises:

How much is one allowed to lie to patients in order to elicit a placebo effect?

Is is OK if the practitioner believes it is a placebo but gives it anyway?

Is it OK if the pratitioner believes that it is not a placebo when actually it is?

Is it OK for practitioners to go degrees taught by people who believe that it is not a placebo when actually it is?

The report fails to face frankly these dilemmas. The present rather absurd position in which it is considered unethical for a medical practitioner to give a patient a bottle of pink water, but
perfectly acceptable to refer them to a homeopath. There is no sign either of taking into account the cultural poison that is spread by telling people about yin, yang and meridians and such like preposterous made-up mumbo jumbo. That is part of the cost of endorsing placebos. And just when one thought that believing things because you wished they were true was going out of fashion

Once again we hear a lot about the alleged difficulties posed by research on alternative medicine. These alleged difficulties are, in my view, mostly no more than excuses. There isn’t the slightest
difficulty in testing things like herbal medicine or homeopathy, in a way that preserves all the ‘context’ and the ways of working of homeopaths and herbalists. Anyone who reads the Guardian knows
how to do that.

In the case of acupuncture, great ingenuity has gone into divising controls. The sham and the ‘real’ acupuncture always come out the same. In a non-blind comparison between acupuncture and no acupuncture the latter usually does a bit worse, but the effects are small and transient and entirely compatible with the view that it is a theatrical placebo.

Despite these shortcomings, some of the conclusions [p. 22] are reasonable.

“The public needs more robust evidence to make informed decisions about the use of complementary practice.

Commissioners of public health care need more robust evidence on which to base decisions about expenditure of public money on complementary practice.”

What the report fails to do is to follow this with the obvious conclusion that such evidence is largely missing and that until such time as it is forthcoming there should be no question of the NHS paying for alternative treatments.

Neither should there be any question of giving them official government recognition in the form of ‘statutory regulation’. The folly of doing that is illustrated graphically by the case of chiropractic which is now in deep crisis after inspection of its claims in the wake of the Simon Singh defamation case. Osteopathy will, I expect, suffer the same fate soon.

In the summary on p.12 we see a classical case of the tension

Controlled trials of effectiveness and cost-effectiveness are of primary importance

We recognise that it is the assessment of effectiveness that is of primary importance in reaching a judgement of different practices. Producing robust evidence that something works in practice – that it is effective – should not be held up by the inevitably partial findings and challenged interpretations arising from inquiries into how the intervention works.

The headline sounds impeccable, but directly below it we see a clear statement that we should use treatments before we know whether they work. “Effectiveness”, in the jargon of the alternative medicine business, simply means that uncontrolled trials are good enough. The bit about “how it works” is another very common red herring raised by alternative medicine people. Anyone who knows anything about pharmacology that knowledge about how any drug works is incomplete and often turns out to be wrong. That doesn’t matter a damn if it performs well in good double-blind randomised controlled trials.

One gets the impression that the whole thing would have been a lot worse without the dose of reality injected by Richard Lilford. He is quoted as a saying

“All the problems that you find in complementary medicine you will encounter in some other kind of treatment … when we stop and think about it… how different is it to any branch of health care – the answer to emerge from our debates is that it may only be a matter of degree.” [p. 17]

I take that to mean that alternative medicine poses problems that are no different from other sorts of treatment. They should be subjected to exactly the same criteria. If they fail (as is usually the case) they should be rejected. That is exactly right. The report was intended to produce consensus, but throughout the report, there is a scarcely hidden tension between believers on one side, and Richard Lilford’s impeccable logic on the other.

It bills this report on its home page as “New research methods needed to build evidence for the effectiveness of popular complementary therapies”. But in fact the report doesn’t really recommend ‘new research methods’ at all, just that the treatments pass the same tests as any other treatment. And note the term ‘build evidence’. It carries the suggestion that the evidence will be positive. Experience in the USA (and to a smaller extent in the UK) suggests that every time some good research is done, the effect is not to ‘build evidence’ but for the evidence to crumble further

If the advice is followed, and the results are largely negative, as has already happened in the USA, the Department of Health would look pretty silly if it had insisted on degrees and on statutory regulation.

The King’s Fund chairman is Sir Cyril Chantler and its Chief Executive is Niall Dickson. It produces reports, some of which are better than this one. I know it’s hard to take seriously an organisation that wants to “share its vision” withyou, but they are trying.

“The King’s Fund was formed in 1897 as an initiative of the then Prince of Wales to allow for the collection and distribution of funds in support of the hospitals of London. Its initial purpose was to raise money for London’s voluntary hospitals,”

It seems to me that the King’s Fund is far too much too influenced by the present Prince of Wales. He is, no doubt, well-meaning but he has become a major source of medical misinformation and his influence in the Department of Health is deeply unconstitutional. I was really surprised to see thet Cyril Chantler spoke at the 2009 conference of the Prince of Wales Foundation for Integrated Health, despite having a preview of the sort of make-believe being propagated by other speakers. His talk there struck me as evading all the essential points. Warm, woolly but in the end, a danger to patients. Not only did he uncritically fall for the spin on the word “integrated”, but he also fell for the idea that “statutory regulation” will safeguard patients.

Revelation of what is actually taught on degrees in these subjects shows very clearly that they endanger the public.

But the official mind doesn’t seem ever to look that far. It is happy ticking boxes and writing vacuous managerialese. It lacks curiosity.

Follow-up

The British Medical Journal published today an editorial which also recommends rebranding of ‘pragmatic’ trials. No surprise there, because the editorial is written by Hugh MacPherson, senior research fellow, David Peters, professor of integrated healthcare and Catherine Zollman, general practitioner. I find it a liitle odd that the BMJ says “Competing Interests: none. David Peters interest is obvious from his job description. It is less obvious that Hugh MacPherson is an acupuncture enthusiast who publishes mostly in alternative medicine journals. He has written a book with the extraordinary title “Acupuncture Research, Strategies for Establishing an Evidence Base”. The title seems to assume that the evidence base will materialise eventually despite a great deal of work that suggests it won’t. Catherine Zollman is a GP who is into homeopathy as well as acupuncture. All three authors were speakers at the Prince of Wales conference, described at Prince of Wales Foundation for magic medicine: spin on the meaning of ‘integrated’.

The comments that follow the editorial start with an excellent contribution from James Matthew May. His distinction between ‘caring’ and ‘curing’ clarifies beautifully the muddled thinking of the editorial.

“At some point a stop has to be put to this continual special pleading. The financial crisis (caused by a quite different group of people who were equally prone to wishful thinking) seems quite a good time to start.”

In my view traditional Chinese medicine endangers people. The proposed ‘regulation’ would do nothing to protect the public. Quite on the contrary, it would add to the dangers, by giving an official stamp of approval while doing nothing for safety.

The government’s idea of improving safety is to make sure that practitioners are ‘properly trained’. But it is the qualifications that cause the danger in the first place. The courses teach ideas that are plain wrong and often really dangerous.

Why have government (and some universities) not noticed this? That’s easy to see. Governments, quangos and university validation committees simply don’t look. They tick boxes but never ask what actually goes on. Here’s some examples of what goes on for them to think about. They show clearly the sort of dangerous rubbish that is taught on some of these ‘degrees’.

These particular slides are from the University of Westminster, but similar courses exist in only too many other places. Watch this space for more details on courses at Edinburgh Napier University, Middlesex University and the University of East London

Just a lot of old myths. Sheer gobbledygook,

SO much for a couple of centuries of physiology,

It gets worse.

Plain wrong.

Curious indeed. The fantasy gobbledygook gets worse.

Now it is getting utterly silly. Teaching students that the brain is made of marrow is not just absurd, but desperately dangerous for anyone unlucky (or stupid) enough to go to such a person when they are ill.

Here’s another herbal lecture., and this time the topic is serious. Cancer.

Herbal approaches for patients with cancer.

I’ve removed the name of the teacher to spare her the acute embarrassment of having these dangerous fantasies revealed. The fact that she probably believes them is not a sufficient excuse for endangering the public. There is certainly no excuse for the university allowing this stuff to be taught as part of a BSc (Hons).

First get them scared with some bad statistics.

No fuss there about distinguishing incidence, age-standardisation and death rates. And no reference. Perhaps a reference to the simple explanation of statistics at Cancer Research UK might help? Perhaps this slide would have been better (from CDC). Seems there is some mistake in slide 2.

Straight on to a truly disgraceful statement in slide 3

The is outrageous and very possibly illegal under the Cancer Act (1939). It certainly poses a huge danger to patients. It is a direct incentive to make illegal, and untrue claims by using weasel words in an attempt to stay just on the right side of the law. But that, of course, is standard practice in alternative medicine,

Slide 11 is mostly meaningless. “Strengthen vitality” sounds good but means nothing. And “enhancing the immune system” is what alternative medicine folks always say when they can think of nothing else. Its meaning is ill-defined and there is no reason to think that any herbs do it.

The idea of a ‘tonic’ was actually quite common in real medicine in the 1950s. The term slowly vanished as it was realised that it was a figment of the imagination. In the fantasy world of alternative medicine, it lives on.

And of course the antioxidant myth is a long-disproved hypothesis that has become a mere marketing term.

“Inhibits the recurrence of cancer”! That sounds terrific. But if it is so good why is it not even mentioned in the two main resources for information about herbs?

In the UK we have the National Library for Health Complementary and Alternative Medicine Specialist Library (NeLCAM), now a part of NHS Evidence. It was launched in 2006. The clinical lead was none other than Peter Fisher, clinical director of the Royal London Homeopathic Hospital, and the Queen’s homeopathic physician. The library was developed with the School of Integrated Health at the University of Westminster (where this particular slide was shown to undergraduates). Nobody could accuse these people of being hostile to magic medicine,

It seems odd, then, that NeLCAM does not seem to thnk to think that Centella asiatica, is even worth mentioning.

In the USA we have the National Center for Alternative and Complementary Medicine (NCCAM), an organisation that is so friendly to alternative medicine that it has spent a billion dollars on research in the area, though it has produced not a single good treatment for that vast expenditure. But NCCAM too does not even mention Centella asiatica in its herb list. It does get a mention in Cochrane reviews but only as a cosmetic cream and as an unproven treatment for poor venous circulation in the legs.

What on earth is a “lymph remedy”. Just another marketing term?

“especially valuable in the treatment of breast, throat and uterus cancer.“

That is a very dramatic claim. It as as though the hapless students were being tutored in doublespeak. What is meant by “especially valuable in the treatment of”? Clearly a desperate patient would interpret those words as meaning that there was at least a chance of a cure. That would be a wicked deception because there isn’t the slightest reason to think it works. Once again there this wondrous cure is not even mentioned in either NELCAM or NCCAM. Phytolacca is mentioned, as Pokeweed, in Wikipedia but no claims are mentioned even there. And it isn’t mentioned in Cochrane reviews either. The dramatic claims are utterly unfounded.

Ah the mistletoe story, again.

NHS Evidence (NeLCAM) lists three completed assessments. One concludes that more research is needed. Another concludes that “Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy”, and the third says “The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak”.

The FDA does not allow injectable mistletoe to be imported, sold, or used except for clinical research (see Question 8).

Cochrane reviews lists several reviews of mistletoe with similar conclusions. For example “The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak”.

Anthroposophy is one of the highest grades of fantasy you can find. A post on that topic is in the works.

“Indicated for cancers . . . colon/rectal, uterine, breast, lung“. A cure for lung cancer? That, of course, depends on how you interpret the weasel words “indicated for”. Even Wikipedia makes no mention of any claims that Thuja benefits cancer. NHS Evidence (NeLCAM) doesn’t mention Thuja for any indication. Neither does NCCAM. Nor Cochrane reviews. That is not the impression the hapless students of this BSc lecture were given. In my view suggestions that you can cure lung cancer with this tree are just plain wicked.

Pure snake oil, and not even spelled correctly, Harry Hoxsey’s treatment centres in the USA were closed by court order in the 1950s.

At least this time it is stated that there is no hard evidence to support this brand of snake oil.

More unfounded claims when it says “treated successfully many cancer patients”. No references and no data to support the claim. It is utterly unfounded and claims to the contrary endanger the public.

Gerson therapy is one of the most notorious and unpleasant of the quack cancer treatments. The Gerson Institute is on San Diego, but their clinics are in Mexico and Hungary. It is illegal in the USA. According to the American Cancer Society you get “a strict low-salt, low-fat, vegetarian diet and drinking juice from about twenty pounds of fresh fruits and vegetables each day. One glass of juice is consumed each hour, thirteen times a day. In addition, patients are given several coffee enemas each day. Various supplements, such as potassium, vitamin B12, pancreatic enzymes, thyroid hormone, and liver extracts, are used to stimulate organ function, particularly of the liver and thyroid.”. At one time you also got several glasses of raw calf liver every day but after infections killed several people] carrot juice was given instead.

Cancer Research UK says “there is no evidence to show that Gerson therapy works as a cure for cancer”, and “The Gerson diet can cause some very serious side effects.” Nobody (except perhaps the Price of Wales) has any belief in this unpleasant, toxic and expensive folk-lore.

Again patients are endangered by teaching this sort of stuff.

And finally, the usual swipe at vaccines. It’s nothing to do with herbalism. but just about every alternative medicine advocate seems to subscribe to the anti-vaccination lobby.. It is almost as though they have an active preference for things that are known to be wrong. They seem to believe that medicine and science are part of an enormous conspiracy to kill everyone.

“NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.”

Its Guidance document on Low Back Pain will be published on Wednesday 27 May 2009, but the newspapers have already started to comment, presumably on the assumption that it will have changed little from the Draft Guidance of September 2008. These comments may have to be changed as soon as the final version becomes available.

The draft guidance, though mostly sensible, has two recommendations that I believe to be wrong and dangerous. The recommendations include (page 7) these three.

Consider offering a course of manual therapy including spinal manipulation of up to 9 sessions over up to 12 weeks.

Consider offering a course of acupuncture needling comprising up to 10 sessions over a period of up to 12 weeks.

Consider offering a structured exercise programme tailored to the individual.

All three of this options are accompanied by a footnote that reads thus.

“A choice of any of these therapies may be offered, taking into account patient preference.”

On the face if it, this might seem quite reasonable. All three choices seem to be about as effective (or ineffective) as each other, so why not let patients choose between them?

Actually there are very good reasons, but NICE does not seem to have thought about them. In the past I have had a high opinion of NICE but it seems that even they are now getting bogged down in the morass of political correctness and officialdom that is the curse of the Department of Health. It is yet another example of DC’s rule number one.

Never trust anyone who uses the word ‘stakeholder’.

They do use it, often.

So what is so wrong?

For a start, I take it that the reference to “spinal manipulation” in the first recommendation is a rather cowardly allusion to chiropractic. Why not say so, if that’s whar you mean? Chiropractic is mentioned in the rest of the report but the word doesn’t seem to occur in the recommendations. Is NICE perhaps nervous that it would reduce the credibility of the report if the word chiropractic were said out loud?

Well, they have a point, I suppose. It would.

That aside, here’s what’s wrong.

The Evidence

I take as my premise that the evidence says that no manipulative therapy has any great advantage over the others. They are all more or less equally effective. Perhaps I should say, more or less equally ineffective, because anyone who claims to have the answer to low back pain is clearly deluded (and I should know: nobody has fixed mine yet). So for effectiveness there are no good grounds to choose between exercise, physiotherapy, acupuncture or chiropractic. There is, though, an enormous cultural difference. Acupuncture and chiropractic are firmly in the realm of alternative medicine. They both invoke all sorts of new-age nonsense for which there isn’t the slightest good evidence. That may not poison your body, but it certainly poisons your mind.

Acupuncturists talk about about “Qi”, “meridians”, “energy flows”. The fact that “sham” and “real” acupuncture consistently come out indistinguishable is surely all the evidence one needs to dismiss such nonsense. Indeed there is a small group of medical acupuncturists who do dismiss it. Most don’t. As always in irrational subjects, acupuncture is riven by internecine strife between groups who differ in the extent of their mystical tendencies,

Chiropractors talk of “subluxations”, an entirely imaginary phenomenon (but a cause of much unnecessary exposure to X-rays). Many talk of quasi-religious things like “innate energy”. And Chiropractic is even more riven by competing factions than acupuncture. See, for example, Chiropractic wars Part 3: internecine conflict.

The bait and switch trick

This is the basic trick used by ‘alternative therapists’ to gain respectability.

There is a superb essay on it by the excellent Yale neurologist Steven Novella: The Bait and Switch of Unscientific Medicine. The trick is to offer some limited and reasonable treatment (like back manipulation for low back pain). This, it seems, is sufficient to satisfy NICE. But then, once you are in the showroom, you can be exposed to all sorts of other nonsense about “subluxations” or “Qi”. Still worse, you will also be exposed to the claims of many chiropractors and acupuncturists to be able to cure all manner of conditions other than back pain. But don’t even dare to suggest that manipulation of the spine is not a cure for colic or asthma or you may find yourself sued for defamation. The shameful legal action of the British Chiropractic Association against Simon Singh (follow it here) led to an addition to DC’s Patients’ Guide to Magic Medicine.
(In the face of such tragic behaviour, one has to be able to laugh).

Libel: A very expensive remedy, to be used only when you have no evidence. Appeals to alternative practitioners because truth is irrelevant.

NICE seems to have fallen for the bait and switch trick, hook line and sinker.

The neglected consequences

If acupuncture is recommended we will have acupuncturists telling patients about utterly imaginary things like “Qi” and “meridians”. And we will have chiropractors telling them about subluxations and innate energy. It is my opinion that these things are simply make-believe (and that is also the view of a minority of acupuncturist and chiropractors). That means that you have to decide whether the supposed benefits of the manipulation are sufficient to counterbalance the deception of patients.

Some people might think that it was worth it (though not me). What is unforgivable is not to consider even the question. The NICE guidance says not a word about this dilemma. Why not?

The training dilemma

The training dilemma is even more serious. Once some form of alternative medicine has successfully worked the Bait and Switch trick and gained a toehold in the NHS, there will be an army of box-ticking HR zombies employed to ensure that they have been properly trained in “subluxations” or “Qi”. There will be quangos set up to issue National Occupational Standards in “subluxations” or “Qi”. Skills for Health will issue “competences” in “subluxations” or “Qi” (actually they already do). There will be courses set up to teach about “subluxations” or “Qi”, some even in ‘universities’ (there already are).

The respectability problem

But worst of all, it will become possible for aupuncturists and chiropractors to claim that they now have official government endorsement from a prestigious evidence-based organisation like NICE for “subluxations” or “Qi”. Of course this isn’t true. In fact the words “subluxations” or “Qi” are not even mentioned in the draft report. That is the root of the problem. They should have been. But omitting stuff like that is how the Bait and Switch trick works.

Alternative medicine advocates crave, above all, respectability and acceptance. It is sad that NICE seems to have given them more credibility and acceptance without having considered properly the secondary consequences of doing so,

How did this failure of NICE happen?

It seems to have been a combination of political correctness, failure to consider secondary consequences, and excessive influence of the people who stand to make money from the acceptance of alternative medicine.

Take, for example, the opinion of the British Pain Society. This organisation encompasses not just doctors. It
includes “doctors, nurses, physiotherapists, scientists, psychologists, occupational therapists and other healthcare professionals actively engaged in the diagnosis and treatment of pain and in pain research for the benefit of patients”. Nevertheless, their response to the draft guidelines pointed out that the manipulative therapies as a whole were over-represented.

Manipulation

The guidelines assess 9 large groups of interventions of which manual therapies are only one part. The full GDG members panel of 13 individuals included two proponents of spinal manipulation/mobilisation (P Dixon and S Vogel). In addition, the chair of the panel (M Underwood) is the lead author of the UKBEAM trial on which the positive recommendation for
manipulation/mobilisation seems to predominately rest. Proponents of spinal manipulation/mobilisation were therefore over-represented in the generation of these guidelines, which, in turn could have generated the over-optimistic conclusion regarding this intervention.

It seems that the Pain Society were quite right.

LBC 97.3 Breakfast Show (25 May 2009) had a quick discussion on acupuncture (play mp3 file). After I had my say, the other side was put by Rosey Grandage. She has (among other jobs) a private acupuncture practice so she is not quite as unbiassed as me). As usual, she misrepresents the evidence by failing to distinguish between blind and non-blind studies. She also misrepresented what I said by implying that I was advocating drugs. That was not my point and I did not mention drugs (they, like all treatments, have pretty limited effectiveness, and they have side effects too). She said “there is very good evidence to show they (‘Qi’ and ‘meridians’] exist”. That is simply untrue.

There can’t be a better demonstration of the consequences of falling for bait and switch than the defence mounted by Rosey Grandage. NICE may not mention “Qi” and “meridians”; but the people they want to allow into the NHS have no such compunctions.

I first came across Rosey Grandage when I discovered her contribution to the Open University/BBC course K221. That has been dealt with elsewhere. A lot more information about acupuncture has appeared since then. She doesn’t seem to have noticed it. Has she not seen the Nordic Cochrane Centre report? Nor read Barker Bausell, or Singh & Ernst? Has she any interest in evidence that might reduce her income? Probably not.

Where to find out more

An excellent review of chiropractic can be found at the Layscience site. It was written by the indefatigable ‘Blue Wode’ who has provided enormous amounts of information at the admirable ebm-first site (I am authorised to reveal that ‘Blue Wode’ is the author of that site). There you will also find much fascinating information about both acupuncture and about chiropractic.
I’m grateful to ‘Blue Wode’ for some of the references used here.

Alfred Joseph Clark FRS held the established chair of Pharmacology at UCL from 1919 to 1926, when he left for Edinburgh. In the 1920s and 30s, Clark was a great pioneer in the application of quantitative physical ideas to pharmacology. As well as his classic scientific works, like The Mode of Action of Drugs on Cells (1933) he wrote, and felt strongly, about the fraud perpetrated on the public by patent medicine salesmen. In 1938 (while in Edinburgh) he published a slim volume called Patent Medicines. The parallels with today are astonishing.

Alfred Joseph Clark FRS (1885 – 1941)

I was lucky to be given a copy of this book by David Clark, A.J. Clark’s eldest son, who is now 88. I visited him in Cambridge on 17 September 2008, because he thought that, as holder of the A.J. Clark chair at UCL from 1985 to 2004, I’d be a good person to look after this and several other books from his father’s library. They would have gone to the Department of Pharmacology if we still had one, but that has been swept away by mindless administrators with little understanding of how to get good science.

Quotations from the book are in italic, and are interspersed with comments from me.

The book starts with a quotation from the House of Commons Select Committee report on Patent Medicines. The report was submitted to the House on 4 August 1914, so there is no need to explain why it had little effect. The report differs from recent ones in that it is not stifled by the sort of political correctness that makes politicians refer to fraudsters as “professions”.

The problem

“2.2 The situation, therefore, as regards the sale and advertisement of proprietary medicines and articles may be summarised as follows:

For all practical purposes British law is powerless to prevent any person from procuring any drug, or making any mixture, whether patent or without any therapeutical activity whatever (as long as it does not contain a scheduled poison), advertising it in any decent terms as a cure for any disease or ailment, recommending it by bogus testimonials and the invented opinions and facsimile signatures of fictitious physicians, and selling it under any name he chooses, on payment of a small stamp duty. For any price he can persuade a credulous public to pay.”

Select Committee on Patent Medicines. 1914

“The writer has endeavoured in the present article to analyse the reasons for the amazing immunity of patent medicines form all attempts to curb their activity, to estimate the results and to suggest the obvious measures of reform that are needed.”

Clark, writing in 1938, was surprised that so little had changed since 1914. What would he have thought if he had known that now, almost 100 years after the 1914 report, the fraudsters are still getting away with it?

Chapter 2 starts thus.

THE LAW

The Select Committee appointed by the House of Commons in 1914 ‘to consider and inquire into the question of the sale of Patent and Proprietary Medicines’ stated its opinion in 28 pages of terse and uncompromising invective. Its general conclusions were as follows:

That the trade in secret remedies constituted a grave and widespread public evil.

That the existing law was chaotic and had proved inoperative and that consequently the traffic in secret remedies was practically uncontrolled.

In particular it concluded ‘”that this is an intolerable state of things and that new legislation to deal with it, rather than merely the amendment of existing laws, is urgently needed in the public interest.”

The “widespread public evil”continues almost unabated, and rather than introduce sensible legislation to cope with it, the government has instead given a stamp of approval for quackery by introducing utterly ineffective voluntary “self-regulation”.

Another Bill to deal with patent medicines was introduced in 1931, without success, and finally in 1936, a Medical and Surgical Appliances (Advertisement) Bill was introduced. This Bill had a very limited scope. Its purpose was to alleviate some of the worst abuses of the quack medicine trade by prohibiting the advertisement of cures for certain diseases such as blindness, Bright’s disease [nephritis] , cancer, consumption [tuberculosis], epilepsy, fits, locomotor ataxy, fits, lupus or paralysis.

The agreement of many interests was secured for this measure. The president of the Advertising Association stated that the proposed Bill would not affect adversely any legitimate trade interest. Opposition to the Bill was, however, whipped up amongst psychic healers, anti-vivisectionists and other opponents of medicine and at the second reading in March 1936, the Bill was opposed and the House was counted out during the ensuing debate. The immediate reason for this fate was that the Bill came up for second reading on the day of the Grand National! This is only one example of the remarkable luck that has attended the patent medicine vendors.
(Page 14).

The “remarkable luck” of patent medicine vendors continues to this day, Although, in principle, advertisement of cures for venereal diseases was banned in 1917, and for cancer in 1939, it takes only a few minutes with Google to find that these laws are regularly flouted by quacks, In practice quacks get away with selling vitamin pills for AIDS, sugar pills for malaria and homeopathic pills for rabies, polio anthrax and just about anything else you can think of. Most of these advertisements are contrary to the published codes of ethics of the organisations to which the quack in question belongs but nothing ever happens.Self-regulation simply does not work, and there is still no effective enforcement even of existing laws..

“It has already been stated that British law allows the advertiser of a secret remedy to tell any lie or make any claim that he fancies will sell his goods and the completeness of this licence is best illustrated by the consideration of a few specific points.

Advertisements for secret remedies very frequently contain a list of testimonials from medical men, which usually are in an anonymous form, stating that ………….. M.D., F.R.C.S., has found the remedy infallible. Occasionally, however, the name and address of a doctor is given and anyone unaware of the vagaries of English law would imagine that such use of a doctor’s name and professional reputation could not be made with impunity without his consent. In 1899, however, the Sallyco Mineral Water Company advertised that ‘Dr. Morgan Dochrill, physician to St. John’s Hospital, London and many of the leading physicians are presenting ‘Sallyco’ as an habitual drink. Dr. Dochrill says nothing has done his gout so much good.
Dr. Dochrill, whose name and title were correctly stated above, sued the company but failed in his case. ”

“The statement that the law does not prevent the recommending of a secret remedy by the use of bogus testimonials and facsimile signatures of fictitious physicians is obviously an understatement since it is doubtful how far it interferes with the use of bogus testimonials from real physicians.”

Dodgy testimonials are still a mainstay of dodgy salesman. One is reminded of the unauthorised citation of testimonials from Dr John Marks and Professor Jonathan Waxman by Patrick Holford to aid his sales of unnecessary vitamin supplements. There is more on this at Holfordwatch.

The man in the street knows that the merits of any article are usually exaggerated in advertisements and is in the habit of discounting a large proportion of such claims, but, outside the realm of secret remedies, the law is fairly strict as regards definite misstatements concerning goods offered for sale and hence the everyday experience of the man in the street does not prepare him for dealing with advertisements which are not merely exaggerations but plain straightforward lies from beginning to end.

Scientific training is undoubtedly a handicap in estimating popular gullibility as regards nostrums. One imagines that no one today would be willing to spend money on pills guaranteed to prevent earthquakes but yet the claims of many of the remedies offered appear equally absurd to anyone with an elementary
knowledge of physiology or even of chemistry. A study of the successes and failures suggests that success depends chiefly on not over-rating the public intelligence. (Page 34)

This may have changed a bit since A.J. Clark was writing in 1938. Now the main clients of quacks seem to be the well-off “worried-well”. But it remains as true as ever that “Scientific training is undoubtedly a handicap in estimating popular gullibility as regards nostrums.” In 2008, it is perhaps more a problem of Ben Goldacre’s dictum ““My basic hypothesis is this: the people who run the media are humanities graduates with little understanding of science, who wear their ignorance as a badge of honour.”

Clark refers (page 36) to a successful conviction for fraud in the USA in 1917. The subject was a widely advertised ‘get fat quick’ pill that contained lecithin, proteins and sugar. The BMA analysis (in 1912)
suggested that the cost of the ingredients in a box of 30 tablets sold for 4/6 was 1 1/4 d. [4/6 meant 4 shillings and six pence, or 22.5 pence since 1971, and 1 1/4 old pence, a penny farthing, is 0.52 new pence]. He comments thus.

The trial revealed many interesting facts. The formula was devised after a short consultation with the expert of one of the largest drug manufacturers in the U.S.A. This firm manufactured the tablets and sold them to the proprietary medicine company at about 3/- per 1000, whilst they were retailed to the public at the rate of £7 10s. per 1000. The firm is estimated to have made a profit of about $3,000,000.

These trials in the U.S.A. revealed the fact that in a considerable proportion of cases the ‘private formula’ department of the large and well known drug firm already mentioned had first provided the formula for the nostrum and subsequently had prepared it wholesale.

Nothing much has changed here either. The alternative medicine industry (and it is a very big industry) is fond of denouncing the evils of the pharmaceutical industry, and sadly, occasionally they are right. One of the less honest practices of the pharmaceutical industry (though one never mentioned by quacks) is buying heavily into alternative medicine. Goldacre points out

“there is little difference between the vitamin and pharmaceutical industries. Key players in both include multinationals such as Roche and Aventis; BioCare, the vitamin pill producer that media nutritionist Patrick Holford works for, is part-owned by Elder Pharmaceuticals.”

The manner in which secret remedies can survive repeated exposure is shown by the following summary of the life history of a vendor of a consumption [tuberculosis] cure.

1904, 1906: Convicted of violating the law in South Africa.

1908: Exposed in British Medical Association report and also attacked by Truth.

1910: Sued by a widow. The judge stated: ‘I think this is an intentional and well-considered fraud. It is a scandalous thing that poor people should be imposed upon and led to part with their money, and to hope that those dear to them would be cured by those processes which were nothing but quack remedies and had not the slightest value of any kind.’

1914: A libel action against the British Medical Association was lost.

1915 The cure was introduced into the United States.

1919 The cure was sold in Canada.

1924 Articles by men with medical qualifications appeared in the Swiss medical journal boosting
the cure.

Secret remedies have a vitality that resembles that of the more noxious weeds and the examples mentioned suggest that nothing can do them any serious harm.

Most of the time, quacks get away with claims every bit as outrageous today. But Clark does give one example of a successful prosecution. It resulted from an exposé in the newspapers -wait for it -in the Daily Mail.

There is, however, one example which proves that a proprietary remedy can be squashed by exposure if this is accompanied by adequate publicity.

The preparation Yadil was introduced as an antiseptic and was at first advertised to the medical profession. The proprietor claimed that the remedy was not secret and that the active principle was ‘tri-methenal allylic carbide’. The drug acquired popularity in the influenza epidemic of 1918 and the proprietor became more and more ambitious in his therapeutic claims. The special virtue claimed for Yadil was that it would kill any harmful organism that had invaded the body. A more specific claim was that consumption in the first stage was cured with two or three pints whilst advanced cases might require a little more. Other advertisements suggested that it was a cure for most known diseases from cancer downwards.

These claims were supported by an extraordinarily intense advertising campaign. Most papers, and even magazines circulating amongst the wealthier classes, carried full page and even double page advertisements. The Daily Mail refused these advertisements and in 1924 published a three column article by Sir William Pope, professor of Chemistry in the University of Cambridge. He stated that
the name ‘tri-methenal allylic carbide’ was meaningless gibberish and was not the chemical definition of any known substance. He concluded that Yadil consisted of :

‘About one per cent of the chemical compound formaldehyde.

About four per cent of glycerine.

About ninety-five per cent of water and, lastly, a smell.

He calculated that the materials contained in a gallon cost about 1/6, whilst the mixture was sold at £4 10s. per gallon.

This exposure was completely successful and the matter is of historic interest in that it is the only example of the career of a proprietary medicine being arrested by the action of the Press.

Clark goes on to talk of the law of libel.

“On the other hand the quack medicine vendor can pursue his advertising campaigns in the happy assurance that, whatever lies he tells, he need fear nothing from the interference of British law. The law does much to protect the quack medicine vendor because the laws of slander and libel are so severe.”

The law of libel to this day remains a serious risk to freedom of speech of both individuals and the media. Its use by rogues to suppress fair comment is routine. My first encounter was when a couple of herbalists
threatened to sue UCL because I said that the term ‘blood cleanser’ is gobbledygook. The fact that the statement was obviously true didn’t deter them for a moment. The herbalists were bluffing no doubt, but they caused enough nuisance that I was asked to take my pages off UCL’s server. A week later I was invited back but by then I’d set up a much better blog and the publicity resulted in an enormous increase in readership, so the outcome was good for me (but bad for herbalists).

It was also good in the end for Andy Lewis when his immortal page “The gentle art of homoeopathic killing” (about the great malaria scandal) was suppressed. The Society of Homeopaths’ lawyers didn’t go for him personally but for his ISP who gave in shamefully and removed the page. As a result the missing page reappeared in dozens of web sites round the world and shot to the top in a Google search.

Simon Singh, one of the best science communicators we have, has not been so lucky. He is going to have to defend in court an action brought by the British Chiropractic Association because of innocent opinions expressed in the Guardian.

Chapter 6 is about “The harm done by patent medicines”. It starts thus.

“The trade in secret remedies obviously represents a ridiculous waste of money but some may argue that, since we are a free country and it pleases people to waste their money in this particular way, there is no call for any legislative interference. The trade in quack medicines cannot, however, be regarded as a harmless one. The Poisons Acts fortunately prevent the sale of a large number of dangerous drugs, but there are numerous other ways in which injury can be produced by these remedies.”

The most serious harm, he thought, resulted from self-medication, and he doesn’t mince his words.

“The most serious objection to quack medicines is however that their advertisements encourage self-medication as a substitute for adequate treatment and they probably do more harm in this than in any other manner.

The nature of the problem can best be illustrated by considering a simple example such as diabetes. In this case no actual cure is known to medicine but, on the other hand, if a patient is treated adequately by insulin combined with appropriate diet, he can be maintained in practically normal health, in spite of his disability, for an indefinite period. The expectation of life of the majority of intelligent diabetics, who make no mistakes in their regime, is not much less than that of normal persons. The regime is both irksome and unpleasant, but anyone who persuades diabetics to abandon it, is committing manslaughter as certainly as if he fired a machine gun into a crowded street.

As regards serious chronic disease the influence of secret remedies may be said to range from murderous to merely harmful.

‘Cures’ for consumption, cancer and diabetes may fairly be classed as murderous, since they are likely to cause the death of anyone who is unfortunate enough to believe in their efficacy and thus delay adequate treatment until too late.

The phrase “‘Cures for consumption, cancer and diabetes may fairly be classed as murderous” made Clark himself the victim of suppression of freedom of speech by lawyers. His son, David Clark, wrote of his father in “Alfred Joseph Clark, A Memoir” (C. & J. Clark Ltd 1985 ISBN 0-9510401-0-3)

“Although tolerant of many human foibles, A. J. had always disapproved fiercely of quacks, particularly the charlatans who sold fraudulent medicines. During his visits to London he met Raymond Postgate, then a crusading left wing journalist, who persuaded A.J. to write a pamphlet which was published in an ephemeral series called ‘Fact‘ in March 1938. It was a lively polemical piece. . To A.J.’s surprise and dismay he was sued for libel by a notorious
rogue who peddled a quack cure for for tuberculosis. This man said that A.J.’s remarks (such as “‘Cures’ for consumption, cancer and diabetes may fairly be classed as murderous”) were libellous and would damage his business. A.J. was determined to fight, and he and Trixie decided to put their savings at stake if necessary. The B.M.A. and the Medical Defence Union agreed to support him and they all went to lawyers. He was shocked when they advised him that he would be bound to lose for he had damaged the man’s livelihood! Finally, after much heart searching, he made an apology, saying that he had not meant that particular man’s nostrum”

Talk about déjà vu!

On page 68 there is another very familiar story. It could have been written today.

“The fact that the public is acquiring more knowledge of health matters and is becoming more suspicious of the cruder forms of lies is also helping to weed out the worst types of patent medicine advertisements. For example, in 1751 a bottle of oil was advertised as a cure for scurvy, leprosy and consumption but today such claims would not be effective in promoting the sale of a remedy. The modern advertiser would probably claim that the oil was rich in all the vitamins and the elements essential for life and would confine his claims to a statement that it would alleviate all minor forms of physical or mental ill-health.

The average patent medicine advertised today makes plausible rather than absurd claims and in general the advertisements have changed to conform with a change in the level of the public’s knowledge.

It is somewhat misleading, however, to speak of this as an improvement, since the law has not altered and hence the change only means that the public is being swindled in a somewhat more skilful manner.

The ideal method of obtaining an adequate vitamin supply is to select a diet containing an abundant supply of fresh foods, but unfortunately the populace is accustomed to live very largely on preserved or partially purified food stuffs and such processes usually remove most of the vitamins.”

The first part of the passage above is reminiscent of something that A.J Clark wrote in the BMJ in 1927. Nowadays it is almost unquotable and I was told by a journal editor that it was unacceptable even with asterisks. That seems to me a bit silly. Words had different connotations in 1927.

“The less intelligent revert to the oldest form of belief and seek someone who will make strong magic for them and defeat the evil spirits by some potent charm. This is the feeling to which the quack appeals; he claims to be above the laws of science and to possess some charm for defeating disease of any variety.

The nature of the charm changes with the growth of education. A naked n****r howling to the beat of a tom-tom does not impress a European, and most modern Europeans would be either amused or disgusted by the Black mass that was popular in the seventeenth century. Today some travesty of physical science appears to be the most popular form of incantation.”

Apart from some of the vocabulary, what better description could one have of the tendency of homeopaths to harp on meaninglessly about quantum theory or the “scienciness” and “referenciness” of
modern books on nutritional therapy?

So has anything changed?

Thus far, the outcome might be thought gloomy. Judging by Clark’s account, remarkably little has changed since 1938, or even since 1914. The libel law in the UK is as bad now as it was then. Recently the United Nations Human Rights Committee said UK laws block matters of public interest and encourage libel tourism (report here, see also here). It is unfit for a free society and it should be changed.

But there are positive sides too. Firstly the advent of scientific bloggers has begun to have some real influence. People are no longer reliant on journalists to interpret (or, often, misinterpret) results for them. They can now get real experts and links to original sources. Just one of these, Ben Goldacre’s badscience.net, and his weekly column in the Guardian has worked wonders in educating the public and improving journalism. Young people can, and do, contribute to the debate because they can blog anonymously if they are frightened that their employer might object.

Perhaps still more important, the law changed this year. Now, at last, it may be possible to prosecute successfully those who make fraudulent health claims. Sad to say, this was not an initiative of the UK government, which remains as devoted as ever to supporting quacks. Remember that, quite shamefully, the only reason given by the Medicines and Health Regulatory Authority (MHRA) gave for allowing false labelling of homeopathic pills was to support the “homeopathic industry”. They suggested (falsely) that the EU required them to take this irresponsible step, which was condemned by just about every scientific organisation. But the new unfair trading regulations did come from the EU. After almost 100 years since the 1914 report, we have at last some decent legislation. Let’s hope it’s enforced.

Postcript

The back cover of the series of ‘Fact‘ books in which A.J. Clark’s article appeared is reproduced below, simply because of the historical portrait of the 1930s that it gives.

The Times today has given s good showing for my comment piece. It gives the case against following the advice of the Pittilo report. It simply makes no sense to have government regulation of acupuncture, herbal medicine, traditional Chinese medicine until such time as there is evidence that they work. It makes even less sense to have BSc degrees in them. The Department of Health should have more sense that to use the Prince of Wales as its scientific advisor.

Let’s hope that the recent example set by the University of Central Lancashire is the start of trend for vice-chancellors to appreciate that running such degrees brings their universities into disrepute.

I can only apologise for the dreadful title that The Times’ sub-editors put on the piece, My original title was

A bad report for the vice chancellor

The Pittilo report to the Department of Health will endanger the public and corrupt universities. There is a better way.

I like that much better than “Regulate quack nedicine? I feel sick”.

But, oh dear, the picture that I sent them is on the left, but what appeared is on the right. Spot the difference.

A reply from Professor Pittilo

Regulation of acupuncture and herbal medicine has been subject to much scrutiny

Sir, Professor Colquhoun’s campaign to discredit our report (“Regulate quack medicine? I feel sick,” Aug 29) is in danger of placing public health at risk. He is entitled to challenge existing evidence for the effectiveness of complementary and alternative medicine (CAM) but fails to acknowledge the key recommendation from the steering group on the essential need to demonstrate efficacy, safety and quality assurance as a prerequisite for NHS funding.

Professor Colquhoun dismisses CAM because of the absence of a rigorous scientific foundation and he asserts that to teach and practise it is unethical. Survey data consistently demonstrates very high demand for CAM with one report estimating that 22 million visits involving 10.6 per cent of the population in England alone occurred in 2008. This demand is one reason why his alternative model of trade law enforcement will not work. He may argue that these people are uncritical recipients of nonsense, but data from the Medicines and Healthcare products Regulatory Agency confirm that they are at significant risk from poor practice. It is essential that we protect the public by implementing statutory regulation alongside demanding evidence of efficacy. Professor Colquhoun’s resistance to the teaching of science to CAM practitioners will do little to help them to critically evaluate effectiveness.

Science vital to health study

28 August 2008

Your feature on some members of staff at the University of Central Lancashire attacking science degrees in complementary and alternative medicine (“Staff attack science degrees in alternative health”, 7 August) raises a number of concerns.

It is up to any university, taking account of the expert views of staff and external peer review, to determine the appropriate title and award for any degree. It is encouraging to note from the feature that new courses
in acupuncture and Chinese herbal medicine “contain significant elements of science”.

The recent report to Ministers from the Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and other Traditional Medicine
Systems Practised in the UK recognises the significant challenges in developing a strong research and evidence base for complementary and alternative medicine (CAM). It also states that the need to demonstrate
benefit is essential if National Health Service resources are to be made available to fund these therapies.

There is no doubt that courses that provide a solid scientific foundation will greatly assist CAM practitioners in establishing evidence-based practice. It would be most unfortunate if the reported resistance to degree titles led to those wishing to practise acupuncture or herbal medicine receiving less hard science than they might have.

To say that acupuncture and herbal medicine degrees have no academic justification appears arrogant in the extreme. Although it is certainly true that some content may not be scientific, this does not invalidate the legitimacy of these courses at degree level, a fact borne out by their successful validation in a number of universities.

R. Michael Pittilo, Principal and vice-chancellor, The Robert Gordon University.

(1) “It is encouraging to note from the feature that new courses in acupuncture and Chinese Herbal medicine “contain significant elements of science”.

For many alternative therapies the “philosophy” is simply incompatible with science. One obvious example is homeopathy. On Mondays and Wednesdays (science days) the students will be required to learn that response increases with dose. On Tuesdays and Thursdays will be taught the opposite. But for the exam they must reproduce only the latter (nonsensical) idea because their aim is to get a job as a homeopath. That makes nonsense of the idea of a university.

(2) His report “recognises the significant challenges in developing a strong research and evidence base for complementary and alternative medicine (CAM)”.

This seems to constitute a recognition that the evidence is still very inadequate. The time to start degrees, and the time to give official government recognition, is after the evidence is in, not before. What happens if you start degrees and then find that the subject is so much nonsense? Well, that has already happened in several areas of course. But the people who accredit the course and who act as external examiners just happen to be fervent believers in that nonsense, so all appears to be well (to bean counters anyway).

(3) “It would be most unfortunate if the reported resistance to degree titles led to those wishing to practise acupuncture or herbal medicine receiving less hard science than they might have.”

There is, as it happens, a great deal of evidence now about acupuncture, but the authors of the report do not seem to be aware of it. I recommend Barker Bausell’s book on the topic. If students are educated science, like what constitutes evidence, and our current understanding of words like “energy”, they would have to disavow the subject that there are supposed to training to practise

(4) “To say that acupuncture and herbal medicine degrees have no academic justification appears arrogant in the extreme.”

No, it is not a matter of arrogance, just a matter of careful attention to the evidence. Attention to evidence was notably absent in Prof Pittilo’s report, perhaps because his committee consisted entirely of people who earn their living from the subjects they were supposed to be assessing.

(5) “ . . a fact borne out by their successful validation in a number of universities”.

I have had the misfortune to have waded through a mound of such validation documents. The one thing they never consider is whether the treatment works. Sad to say, these validations are not worth the paper they are written on.

The Times published a letter from Edzard Ernst and Simon Singh on April 16th. In their forthcoming book, Trick or Treatment? Alternative Medicine on Trial, they go carefully through all the evidence for all sorts of ‘alternative’ treatments. They find some evidence that a handful of them work. For most the answer is ‘not enough evidence’, and for a number there is good evidence that many of them don’t work to any useful extent.

“Sir, For over two decades the Prince of Wales has been actively promoting alternative medicine and his Foundation for Integrated Health continues to encourage the use of treatments such as homoeopathy or reflexology.””In light of this “rigorous scientific evidence”, we strongly advise that the Prince of Wales and the Foundation for Integrated Health withdraw the publications Complementary Health Care: A Guide for Patients and the Smallwood report. They both contain numerous misleading and inaccurate claims concerning the supposed benefits of alternative medicine. The nation cannot be served by promoting ineffective and sometimes dangerous alternative treatments.”

The next day The Times ran an article by their science editor, Mark Henderson, Prince of Wales’s guide to alternative medicine ‘inaccurate’. Natasha Finlayson, of the Prince’s Foundation for Integrated Health, is quoted as saying “The foundation does not promote complementary therapies.”. That takes some beating for sheer bare-faced dishonesty.

Edzard Ernst appeared on the Today Program on 18th April. He was interveiwed by the formidable John Humphrys, along with Kim Lavely, Chief Executive, The Prince’s Foundation for Integrated Health (FIH). Ernst points out that the FIH guide suggests that chiropractic is effective in asthma, and that acupuncture is good for addiction, whereas the evidence says the opposite. Lavely retorts, rather lamely (OK I’m biassed).

Lavely: ” . . . we didn’t attempt to give detailed evidence on every therapy”. “We think they [the public] have the right to know and what doesn’t”

Humphrys: “Well isn’t that the whole point? the professor is saying here is that these things do not work, at least in terms of the claims that are made for them, such as homeopathy and chiropractic . . . ”

Lavely: “There are no claims made in this guide for what works and what doesn’t. What we have said is that some therapies are used for some things but we aren’t saying they are effective for those things . . . “

So, one might ask, what on earth is the use of a guide is it that offers no indication of effectiveness? Lavely’s second quotation contradicts directly her first. A pretty pathetic performance.Listen to the interview [mp3 file]

The Sunday Times, on April 20th, pblished a pretty good review of Trick of Treatment?. “Their case against the folly, vanity and damage of HRH et al. is hard to argue with.”

Of course, the letters column drew the expected response from the quacks, most verging on the hilarious.

Another blow for the alternative industry came in the same week, The authoratitve Cochrane review confirmed earlier reports that vitamin supplements not only do not help you but some actually increase mortality. The antioxidant myth nevertheless rumbles on, and on, and on. There is too much money in it for it to die easily.

Predictably enough, the conclusions were denied by the Health Food Manufacturers’ Association (HFMA). They wheeled out several pop singers to say how wonderful their products are. Read about that pathetic defence on Holfordwatch.

Who is behind HFMA? Incidentally, HFMA are strangely reticent about the identity of their 120 members. They will not reveal who they are. Does anybody out there know the answer? I’ll buy a good dinner for anyone who can root this out. If it is anything like the ‘Health Supplements Information Service‘ it is likely to be backedby the very big pharmaceutical companies that the alternative industry loves to hate.

Take the test

Prince of Wales Guide

“Reflexologists work with a wide range of conditions including certain types of pain, particularly back and neck pain, migraine and headaches, chronic fatigue, sinusitis, arthritis, insomnia, digestive problems such as irritable bowel syndrome, and constipation, stress-related disorders and menopausal symptoms.”

Singh & Ernst

“The notion that reflexology can be used to diagnose health problems has been disproved and there is no convincing evidence that it is effective for any condition.”

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This is an old joke which can be found in many places on the web, with minor variations. I came across it in an article by Gustav Born in 2002 (BIF Futura, 17, 78 – 86) and reproduce what he said. It has never been more relevant, so it’s well worth repeating. The title of the article was British medical education and research in the new century.

“The other deleterious development in UK research is increased bureaucratic control. Bureaucracy is notoriously bad for all creative activities. The story is told of a company chairman who was given a ticket to a concert in which Schubert’s Unfinished Symphony was to be played. Unable to go himself, he passed the ticket on to his colleague, the director in charge of administration and personnel. The next day the chairman asked, ‘Did you enjoy the concert?’ His colleague replied, ‘My report will be on your desk this afternoon’. This puzzled the chairman, who later received the following:

The attendance of the orchestra conductor is unnecessary for public performance. The orchestra has obviously practiced and has the prior authorization from the conductor to play the symphony at a predetermined level of quality. Considerable money could be saved by merely having the conductor critique the performance during a retrospective peer-review meeting.

For considerable periods, the four oboe players had nothing to do. Their numbers should be reduced, and their work spread over the whole orchestra, thus eliminating the peaks and valleys of activity.

All twelve violins were playing identical notes with identical motions. This was unnecessary duplication. If a larger volume is required, this could be obtained through electronic amplification which has reached very high levels of reproductive quality.

Much effort was expended in playing sixteenth notes, or semi-quavers. This seems to me an excessive refinement, as listeners are unable to distinguish such rapid playing. It is recommended that all notes be rounded up to the nearest semi-quaver. If this were done, it would be possible to use trainees and lower-grade operatives more extensively.

No useful purpose would appear to be served by repeating with horns the same passage that has already been handled by the strings. If all such redundant passages were eliminated, as determined by a utilization committee, the concert could have been reduced from two hours to twenty minutes with great savings in salaries and overhead.

In fact, if Schubert had attended to these matters on a cost containment basis, he probably would have been able to finish his symphony.

In research, as in music, blind bureaucracy has the effect of destroying imaginative creativity. If that is truly valued, it must remain free from bureaucratic excesses. And indeed, the great strength of British science has always been the ability of curiosity-driven individuals to follow up original ideas, and the support that these individuals receive from organizations such as the MRC and the Wellcome Trust. This has given research workers the possibility to twist and turn in following up intuitions and ideas in other fields as well as their own. This freedom has been significantly eroded by job insecurity in universities and in commercial enterprises.”

Later in the article, Born talks about innovation in the pharmaceutical industry

“This ‘urge to merge’, which is affecting the pharmaceutical industry worldwide, is almost always claimed to be justified by the need for a larger research budget to sustain innovation. The actual evidence indicates that such mergers hide -for a while failure of innovation. An almost universal response to this problem has been to ‘streamline’ and ‘commercialize’ the process of research, with ultimate control vested in accountants rather than in pharmaceutically informed scientists. This has meant that the industry’s research and development programmes are being driven by technical novelties, notably computer- aided drug design, combinatorial chemistry, high-throughput screening and genomics. All these techniques are very cost-intensive and, what is worse, are superseding individual scientists with profound appreciation of disease mechanisms and knowledge of biochemical and pharmacological mechanisms. It is they whose ability to ask the crucial, often seemingly simple questions, that have led to blockbuster drugs. Outstanding British examples are James Black’s discovery of the gastric acid secretion inhibitors, and Hans Kosterlitz’s question whether the brain might perhaps contain some analgesic chemical like that in -of all things the poppy plant.”

“The fact is that drug discovery, like all discoveries, is more an individual than a team achievement, at least at the beginning. With a few notable exceptions, the trouble with the industry is summarized by a group research director at one of the leading pharmaceutical companies:

“Creative individuals are being driven out of the industry and being replaced by functionaries wbo parrot strategic maxims. Research is being driven by lawyers, financial experts, salesmen and market strategists who are completely unable to develop new ideas. It is doubtful whether there are any senior executives who understand the problem” (Drews, J., 1999 In quest of tomorrow’s medicine, Springer-Verlag, New York).

And further:

“Partly as a result of mismanagement and partly as a result of a search for solutions which takes no account of disease mechanisms and biomedical complexity, substantial parts of the pharmaceutical industry are failing to innovate at a rate which is needed for their health and for the health of the general public. Research management needs to be rethought with a much greater emphasis on creative individuals with a broad knowledge of biology and medicine, a lower emphasis on market research, and a greater openness to the information to be gained from clinical studies (Horrobin, D.F., 2000, Innovation in the pharmaceutical industry. J. R. Soc. Med. 93, 341 – 345. ).”